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CURRENT CAREER OPPORTUNITIES

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There are: 20 Job Openings at Oncobiologics Inc.

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Job Description:

 

Job Description:

Principal Scientist, Upstream Process Development, will be responsible for the development and characterization of robust cell culture processes for biosimilar monoclonal antibodies including micro- to pilot scale bioreactor equipment and filtration processes (e.g. depth). This position will also support the process validation working with Manufacturing.  Principal Scientist, Upstream Process Development, will be responsible for planning, execution, analysis, and reporting of experiments and protocol driven studies related to the development and characterization of manufacturing processes for biosimilars.

Qualifications and Experience:

  • M.S. or Ph.D. in Chemical Engineering, Life Sciences or equivalent
  • Minimum of 10 years progressive industry experience with biologics late phase process development and validation
  • Experience in authoring a BLA/MAA which resulted in approval and marketed product support
  • Experience with statistical methodologies such as DOE, process control charting, multivariate analysis
  • Experience with process and media development for mammalian cell culture along with knowledge of filtration principles and capacity determination
  • Experience with mAbs or similar biologics manufactured utilizing single-use technology is strongly desired
  • Strong understanding of Quality by Design and Risk Management
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records

Position Responsibilities:

This position will lead a team of 2-4 upstream scientists and have the following responsibilities:

 

  • Serve as upstream subject matter expert for all process and manufacturing related activities, including risk assessments, characterization, investigations, regulatory interactions, and project team.
  • Support upstream process control strategy for monoclonal antibodies manufacturing processes.
  • Oversee the execution of upstream process characterization studies.
  • Support tech transfer to manufacturing through authoring and change management of process descriptions (TTPs)
  • Plan and conduct experiments to define upstream manufacturing process parameters or optimized media formulations.
  • Establish and qualify appropriate scale-down models to support process characterization
  • Collaborates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
  • Evaluate opportunities for improving process robustness or reducing Cost of Goods through process optimization
  • Lead development of 2nd generation processes for implementation post-approval
  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions
  • Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline
  • Represent the Company before EU and FDA regulatory authorities

  Location: Cranbury, New Jersey  (map)
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Job Description:

Overview

Director, Cell Culture Process Development, will be responsible for the strategy, development and characterization of robust cell culture processes for biosimilar monoclonal antibodies including micro- to pilot scale bioreactor equipment and filtration processes (e.g. depth). This position will also support the Manufacturing organization.  Director, Cell Culture Process Development, will be responsible for planning, execution, analysis, and reporting of experiments and protocol driven studies related to the development and characterization of manufacturing processes for biosimilars. This position will report to the Executive Director, Process Development

Qualifications:

The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:

 

  • M.S. or Ph.D. in Chemical Engineering, Life Sciences or equivalent
  • Minimum of 10 years progressive industry experience with biologics late phase process development and validation
  • Experience in biotechnology drug development, with clear understanding of CMC requirements
  • Ability to support and effectively multi-task different and complex assignments and responsibilities
  • Understand, identify, mitigate, and communicate risks at the program level
  • Experience with development of stable, high producing mammalian cell lines that meet health authority guidelines
  • Experience in authoring a BLA/MAA which resulted in approval and marketed product support
  • Experience with statistical methodologies such as DOE, process control charting, multivariate analysis
  • Experience with process and media development for mammalian cell culture along with knowledge of filtration principles and capacity determination
  • Experience with mAbs or similar biologics manufactured utilizing single-use technology is strongly desired
  • Strong understanding of Quality by Design and Risk Management
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records

Responsibilities:

This position will lead a team of 4-6 scientists/engineers and have the following responsibilities:

 

  • Have strong interface with cell and molecular biology team with development approach and strategy.
  • Serve as subject matter expert related to upstream process development.  This includes all process and manufacturing related activities, including risk assessments, characterization, investigations, regulatory interactions, and project team requirements.
  • Build a high performing group focused on execution, data analysis.
  • Mentor technical and junior staff to understand technical and regulatory requirements for process development.
  • Support upstream process control strategy for monoclonal antibodies manufacturing processes.
  • Oversee the execution of upstream process characterization studies.
  • Support tech transfer to manufacturing through authoring and change management of process descriptions (TTPs)
  • Plan and conduct experiments to define upstream manufacturing process parameters or optimized media formulations.
  • Establish and qualify appropriate scale-down models to support process characterization
  • Collaborates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
  • Evaluate opportunities for improving process robustness or reducing Cost of Goods through process optimization
  • Lead development of 2nd generation processes for implementation post-approval
  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions
  • Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline as well as other projects that may be assigned
  • Represent the Company before EU and FDA regulatory authorities

  Location: Cranbury, NJ  (map)
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Job Description:

 

Opportunity and Summary of Position:

The Group Leader, Downstream Operations, will execute and oversee all downstream operations as Oncobiologics continues its rapid growth.  The Group Leader, Downstream Operations will be required to ensure cGMP compliant operations occur within the Biologics Manufacturing Center.

 

Position Responsibilities:

Downstream Operations, Group Leader, will report to the Director of Manufacturing with responsibilities including but not limited to:

  • Lead a team of up to 12 FTEs (3 direct and 9 indirect) responsible for the manufacture of clarified harvest to support Oncobiologics Clinical and Commercial needs.
    • Downstream manufacturing oversight from capture chromatography through final UF/DF and bulk aliquoting
    • Scheduling of all downstream manufacturing activities and personnel
  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work may be required based on manufacturing schedule as determined by Area Management.
  • Management of manufacturing operations in accordance with policies and procedures
  • Approval of cGMP documentation as it relates to downstream manufacturing inclusive of SOPs, Batch Records, Deviations, Change Controls, Equipment Qualification Protocols, Technology Transfer Protocols, and Process Validation Protocols.
  • Works with quality assurance management to approve executed documentation in support of drug substance release.
  • Coordination with cross functional areas to ensure that the manufacturing schedule is met. Serves as key stakeholder in meeting when necessary.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Serves as mentor to Supervisors and Operators by fostering the principles of Oncobiologics’ core values.
  • Works with Manufacturing Director and Quality Assurance to establish and execute PAI readiness plan.
  • Management team will assign other responsibilities as required.

 

Qualifications and Experience:

  • MS/BS Degree in Life Sciences or Engineering discipline or equivalent industry experience.
  • Minimum of 12+ years progressive industry experience of biologics drug substance manufacturing environment.  Preference will be given to candidates with commercial manufacturing experience
  • Minimum of 5+ years of supervisory experience in a biologics drug substance manufacturing operation.
  • Expert ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs.
    • Chromatography 
    • Tangential flow filtration
  • Strong working knowledge of cGMP manufacturing operations and ability to maintain regulatory requirements for compliance at all times.
  • Experience with PAI readiness is required
  • Must be able to provide hands-on leadership, coaching, and coordination of needed actions with a focus on achieving production goals.
  • Must have excellent written, verbal, and presentation skills with a demonstrated ability to work effectively in a fast-paced team environment.
  • Must be able to communicate clearly, effectively, and concisely with subordinates, peers and management.
  • Due to international nature of the tasks, fluency in written and spoken English.
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams.
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done.

 

Physical Requirements:

  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
  • Must have the ability to stand for long periods of time.
  • May work in a production environment with exposure to latex and bleach.  Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors.  Following proper safety procedures minimizes potential for exposure.
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
  Location: Cranbury, NJ  (map)
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Job Description:

Opportunity and Summary of Position:

The Quality Control Director oversees Quality Control testing of Oncobiologics Biosimilar products including raw materials, cell banks, in process intermediates, drug substance and drug product. The Quality Control function at Oncobiologics operates under CGMP and this position is directly responsible for maintaining compliance with FDA, ICH and international regulations. In conjunction with Quality Assurance, the Quality Control function at Oncobiologics ensures that products meet established specifications prior to release. The Quality Control Director is also responsible for management of the staff performing Quality Control testing at Oncobiologics and for the oversight of contract laboratories that perform Quality Control testing on behalf of Oncobiologics. 

Qualifications & Experience:  

  • MS or PhD in Chemistry or related subject area.
  • Minimum ten years of experience in quality control of monoclonal antibodies in varying stages of development from pre-clinical to commercial. Small molecule experience is a plus.
  • Knowledge of the following methodologies is necessary: Bioassay, Bioburden, CE-SDS, CEX-HPLC, ELISA, Endotoxin, HCP, HILIC, icIEF, Pro-A HPLC, qPCR, rProtein A, rDNA, SE-HPLC, SE-UPLC and Sterility.

Job Description

The Quality Control Director will report directly to the CEO of Oncobiologics.

 

  • Responsible for the operation of Oncobiologics Quality Control and Stability Labs which provide QC Chemistry and Bioassay support.
  • Oversight of contract laboratories, including those providing QC Chemistry and QC Microbiology.
  • Management, development, training and leadership of Quality Control Staff.
  • Partners with Analytical Sciences to ensure successful development of test methods.
  • Oversees the transfer of methods to Quality Control and the stage appropriate validation of methods.
  • Plans and executes QC testing and performs data review to ensure accuracy, completeness and validity.
  • Establishes specifications.
  • Ensures continuous improvement in productivity and quality.
  • Investigates issues related to Quality Control of Oncobiologics products.

  Location: Cranbury, NJ  (map)
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Job Description:

The Quality Assurance Document Control Specialist will participate in quality oversight of the Document Management and Training System and enforcement of Quality Systems within cGMP operations performed at Oncobiologics.   The Quality Assurance Document Control Specialist reports directly to the Quality Assurance Director or Manager.

Qualifications & Experience:

  • AS or BS degree in Business or Life Sciences is preferred, however, equivalent experience will be considered.
  • Ideal candidate would possess a background in electronic and or paper based Quality Systems for Biologics, Medical Devices or Pharmaceuticals.  Experience in administratingelectronic or paper based systems in other industries will be considered. 
  • Minimum 2 years of experience in pharmaceutical industry or at least 2 years in QA or regulatory affairs role.  Experience in R&D, manufacturing, or technical support is strongly desired as supplementary. Must have exceptional communication skills, both verbal and written, as well as excellent interpersonal and customer service skills.  Experience with Quality Systems such as Document Control and Deviations is preferred.  Must be detail oriented, well organized and able to work independently and on teams.
  • Must be skilled with Microsoft applications (Word, Excel, and PowerPoint). Experience with MasterControl Document and Training modules is a plus.     

Job Description:

 

The Quality Assurance Document Control Specialist will be responsible for supporting the current electronic and paper based quality systems required for biologics manufacturing of clinical supplies and licensed products.

  • Participate in proof reading and formatting documents as they are moved through the review and approval process.
  • Support the Quality Assurance unit with the Document Management and Training System (MasterControl) at Oncobiologics.
  • Maintain the document and archive room.
  • Assist the Quality Assurance team with trainings associated with document management.
  • Responsibilities include archivist for Oncobiologics.
  • Assist QA management with the issuance and tracking of documents used in manufacturing and Quality Control testing.
  • Support business development activities, and solutions for innovation and collaboration as required.
  • Develop customer relationships with peers.
  • Department director may assign other responsibilities as required.

  Location: Cranbury, New Jersey  (map)
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Job Description:

Opportunity and Summary of Position:

Oncobiologics has an immediate opening for Scientist III/IV in Biochemical Characterization in Process Development.  The group supports the process development of monoclonal antibody therapeutics.  The main mission of the group is the development and validation of physicochemical methodologies and process-related impurities assays.  As part of this overall goal, the candidate would be required to develop methodologies, create experimental plans, and execute studies which assess the physicochemical stability of biological drug candidates.  This includes routine and non-routine testing, generating, documenting, and analyzing data for discussions and technical reports.  This position will report to Associate Director – Biochemical Characterization, Process Development.  

Position Responsibilities:

  • Perform routine and non-routine testing to support the process development of monoclonal antibody therapeutics.
  • Develop, validate, and transfer physicochemical methods.
  • Test samples (in-process, drug substances, drug products) using spectroscopy, chromatography, capillary electrophoresis, ELISA, and qPCR.
  • Train junior scientists and maintain and troubleshoot laboratory instruments. 
  • Keep real-time experiment records in ELN and prepare SOPs and reports.
  • Contribute to departmental activities such as safety inspections and internal audits.

Qualifications & Experience:

  • MS/BS in Chemistry/Biochemistry or equivalent (MS preferred)
  • Minimum 5 years of progressive industry experience in the Analytical laboratories in biotechnology or biopharmaceutical industry.
  • Hands-on experience in HPLC/UPLC (e.g. SEC, SEC-MALS, CEX, HILIC, affinity chromatography), SDS-PAGE, capillary electrophoresis (e.g., CE-SDS, cIEF), spectroscopy (UV/VIS), and residual impurity analysis (e.g., ELISA, qPCR).
  • A clear understanding of method development and validation requirements under regulatory guidelines.
  • A thorough understanding of protein structure, chemistry, and stability attributes.
  • An understanding of fundamental biopharmaceutical principles for the development of biologic drug candidates.
  • Basic understanding of statistical data analysis.
  • An ability to effectively and collaboratively participate in team discussions (e.g., communication of test results, OOT results, scientific principles).
  • An ability to prepare clearly written documents (e.g., SOPs, technical reports, method validation reports).
  • Excellent verbal and written communication skills.
  • An ability to work independently with little supervision and be flexible with changing project timeline to support the process development.
  • Experience in the analysis of monoclonal antibody or the late stage biologics support is desirable.
  • Familiarity with CMC and GMP is desirable.
  Location: Cranbury, New Jersey  (map)
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Job Description:

Job Description:

Senior Scientist, Biophysical Characterization, will be responsible for the development, qualification, validation and technical transfer of robust biophysical test methods for biosimilar monoclonal antibodies. Methodologies include but are not limited to high performance liquid chromatography and mass spectrometry.  She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.

Qualifications & Experience:

  • M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or equivalent life science
  • PhD with minimum 2 - 4 years of experience, MS with minimum of 6-8 years of experience, or BS with 8-10 years of experience in the pharmaceutical industry with antibody/protein characterization using various liquid chromatography-mass spectrometry and liquid chromatography methods e.g. peptide mapping for sequencing, variants, post-translational modification, N-linked and O-linked glycosylation characterization
  • Experience with biosimilar development is a plus
  • In-depth understanding of analytical method development, qualification, validation
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams
  • Internal expert on data interpretation, applications and instrumentation and theory in chromatography and mass spectrometry
  • Support the continuous improvement of data quality systems required for the stability testing and filing
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records

 

Job Responsibilities:

This position will report to the Director, Biophysical Characterization.

 

  • Perform method development in glycosylation characterization, primary structure characterization (amino acid sequence, sequence variants, Intact mass, IdeS subunits, disulfide bond conformation, amino acid analysis, extinction coefficient, free thiol content), post-translational modification (oxidation, deamidation, glycation, terminal variants etc.), peptide mapping identity-UPLC, host cell protein using LC-MS
  • Lead the activities of method qualification and validation including preparation and review of protocols, SOPs and reports
  • Lead the sample analysis for biosimilar development and stability studies, CQA assessment, similarity assessment and forced degradation studies
  • Take a lead for troubleshooting of analytical challenges when they arise
  • Develop and implement innovative, value-added assays/platforms to support similarity assessment
  • Provide training to scientists
  • Maintain accurate and timely data records and documentation in both ELN and paper systems
  • Author or participate in peer reviewed publication of scientific work as well as patent applications when appropriate

  Location: Cranbury, NJ  (map)
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Job Description:

Opportunity and Summary of Position:

The QA Specialist, Quality Systems will work with the QA Manager, Quality Systems to ensure that the organization is compliant with relevant cGMPs and assist with the implementation of continuous quality improvements.

Qualifications & Experience:

 

  • BS or MS in Sciences, or equivalent cGxP experience will be considered:  two (2) years in Quality Assurance in the (bio)-pharmaceutical industry.
  • Certification(s) not required.
  • Solid understanding of GMP regulations, CFR 21 Parts 210 and 211.
  • Organized, detail oriented, and can apply critical thinking to problem solving.  Proficient in Microsoft Office.
  • Ability to work independently with moderate management oversight.
  • Contributes to department goals.
  • Auditing experience is a plus.

 

Responsibilities:

    Primary:

  • Assist the QA Manager in Supplier and Contractor qualification, including supplier and contractor qualification status review for periodic requalification.  Occasional travel to conduct and/or support external audits may be required.
  • Provide QA support for Quality Control activities, including internal auditing, calibration/qualification document review, and SOP/Test Method document revision.
  • Assist the QA Manager in administration of the Change Control Quality System, including oversight of change control plans for compliance with target completion date.

 

    Additional responsibilities include:

  • Support for Deviation and Investigation documentation and resolution.
  • Data collection for quality system metrics, including but not limited to Deviations, CAPA, Change Control, Validation and Qualification, Internal and External Audits, etc.
  • Development and implementation of QA procedures.
  • Ensure compliance with relevant cGMPs and ensure readiness for global health authorities’ inspections.
  Location: Cranbury, NJ  (map)
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Job Description:

 

Job Description:

The main mission of the Biochemical Characterization group in Analytical Sciences is the development and validation of physicochemical methodologies and assays for process-related impurities.  As part of this overall goal, the candidate would be required to develop methodologies, create experimental plans, and execute studies which assess the physicochemical stability of biologic drug candidates.  This includes generating, documenting, and analyzing data for team and senior management discussions and development reports.

Qualifications & Experience:

 

  • MS/PhD in Chemistry, Biochemistry, or related field with 6+ years of experience with MS or 4+ years of experience with PhD in the Analytical laboratories in pharmaceutical or biopharmaceutical industry.
  • Must have clear understanding of method development and validation under regulatory guidelines.
  • Must have demonstrated the ability to work independently with little supervision and be flexible with changing project timeline.
  • Solid understanding of the principles and practices of analytical technologies applicable to the biological drug products are required. 
  • Experience in the analysis of monoclonal antibody therapeutics and the basic statistical analysis are highly desirable. 
  • Familiarity with CMC and GMP requirements is desirable.
  • Excellent verbal and written communication skills are required.

Job Responsibilities:

  • Reporting to the Associate Director of Biochemical Characterization, Analytical Sciences. 
  • Perform method development and validation to support the cross-functional team.
  • Perform testing as needed using the instruments such as spectrophotometer, capillary electrophoresis (CE-SDS, cIEF), chromatography (HPLC/UPLC), SEC-MALS, plate reader (ELISA), and qPCR.  
  • Lead junior scientists in the group to provide expertise in instrument maintenance and troubleshooting as well as resolution of OOS and OOT results.
  • Maintain the tidiness in the laboratory while following the safety guidelines provided by EHS.
  • Keep real-time experiment records in ELN and prepare documents (SOP, protocol, report).
  • Contribute to departmental activities such as new instrument purchasing, laboratory safety inspections, and internal audits.
  Location: Cranbury, New Jersey  (map)
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Job Description:

Opportunity and Summary of Position:

The Quality Assurance Specialist will participate in quality oversight of Clinical Supply Manufacturing and enforcement of Quality Systems within cGMP operations performed at Oncobiologics. 

Qualifications & Experience:

 

  • BS degree in Life Sciences, Engineering or Business is preferred, however, equivalent experience will be considered.
  • Ideal candidate would possess a background in manufacturing, quality control or quality assurance for Biologics, Medical Devices or Pharmaceuticals.  Experience in manufacturing or quality systems in other industries will be considered.
  • Minimum 5 years of experience in biopharmaceutical industry or at least 2 years in QA or regulatory affairs.  Experience in R&D, manufacturing, or technical support is strongly desired as supplementary. Must have exceptional communication skills, both verbal and written, as well as excellent interpersonal skills.  Experience with Quality Assurance is preferred.  Must be detail oriented, well organized and able to work independently and on teams.      

Responsibilities:

 

  • The Quality Assurance Specialist will be responsible for issuing, reviewing and archiving executed manufacturing batch records (MBR) for biologics manufacturing of clinical supplies and licensed products.
  • Review and analyse Environmental Monitoring reports.
  • Review and comment on draft documentation relevant to manufacturing, such as MBRs and SOPs
  • Initiate and participate in investigations, including non-conformance events and deviations.
  • Inspect and observe the manufacturing units at Oncobiologics.
  • Ensure that the organization is compliant with relevant cGMPs, participate in internal audit teams and ensure readiness for global health authority’s inspections.
  • Implement Oncobiologics Quality Plan and associated policies and procedures required for the Quality Assurance function.
  • Participate in subcontractor and supplier qualification, including vendor auditing (less than 5% travel expected).
  • Support business development activities, and provide solutions for innovation and collaboration as required.
  • Develop customer relationships with peers.
  • Department director or manager may assign other responsibilities as required.

  Location: Cranbury, NJ  (map)
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Job Description:

Overview:

 

Quality Control Scientists perform Quality Control testing of Oncobiologics Biosimilar products including raw materials, cell banks, in process intermediates, drug substance and drug product. The Quality Control function at Oncobiologics operates under CGMP and this position is directly responsible for maintaining compliance with FDA, ICH and international regulations. In conjunction with Quality Assurance, the Quality Control function at Oncobiologics ensures that products meet established specifications prior to release. 

 

Qualifications & Experience:

 

  • BS or MS in Chemistry or related subject area.
  • Experience in quality control analysis of monoclonal antibodies in varying stages of development from pre-clinical to commercial. Small molecule experience is a plus.
  • Knowledge of some of the following methodologies is plus: Bioassay, Bioburden, CE-SDS, CEX-HPLC, ELISA, Endotoxin, HCP, HILIC, icIEF, Pro-A HPLC, qPCR, rProtein A, rDNA, SE-HPLC, SE-UPLC and Sterility.

 

Job Responsibilities:

 

  • Perform routine testing to support manufacturing and stability. Analyze in-process control samples, drug substances and drug products using UV/Vis, pH, SEC HPLC and compendial assays.
  • Performs data review to ensure accuracy, completeness and validity.
  • Performs routine lab inspections.
  • Participates in safety inspections, internal audits and regulatory inspections.
  Location: Cranbury, NJ  (map)
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Job Description:

 

Opportunity and Summary of Position:

Scientist II/III/IV or Engineer I/II Purification Process Development, is a position that will support the development and characterization of robust purification processes for biosimilar monoclonal antibodies and fusion proteins including chromatography and multiple types of filtration processes. This position will support the Oncobiologics pipeline which spans early and late phase process development needs.  Scientist I/II/III or Engineer I/II, Purification Process Development, will be responsible for contributing to the planning, execution, analysis, and reporting of experiments related to the development of manufacturing processes for biosimilars.  Scientist II/III/IV or Engineer I/II, Purification Process Development, will report to Associate Director, Purification Development.

Job Responsibilities:

 

  • Develop scalable filtration processes including methods for depth filtration, tangential flow filtration, and viral clearance.  This should include working knowledge of filter capacity screening and evaluation.
  • Evaluate chromatography resins and membrane adsorbers (e.g. Protein A, ion exchange, mixed mode, hydrophobic interaction) to be used in purification processes and process models.
  • Perform process characterization studies for purification unit operations, including scale-down model studies, range studies, and resin lifetime studies.
  • Perform viral clearance studies at an offsite contract laboratory.
  • Develop scalable chromatography methods that maximize efficiency of operations in manufacturing.
  • Perform small scale purification in support of cell line and cell culture development organizations.
  • Maintain a current electronic laboratory notebook with scientific rigor to meet project needs for process development.
  • Author and review documentation, including but not limited to, technical transfer protocols and development reports.
  • Present data in team meetings as required.
  • Provide process support to functional areas as needed.
  • Execute process development enabling analytics required to make development decisions rapidly. 
  • Remain current with respect to chromatography techniques and equipment.
  • Operate safely and according to company environmental requirements.
  • Maintain current lab environment (e.g. buffer/solution preparation, raw material ordering, equipment maintenance and repair, hazardous waste disposal).

Qualifications & Experience:

The company is seeking an individual with the following qualifications:

 

  • B.S/M.S/Ph.D Biochemistry, Chemistry, Chemical Engineering or equivalent field. 
  • Minimum 2+ years of experience in absence of graduate degree.  Position will be commensurate with experience.
  • Experience using GE Healthcare AKTA instruments and Unicorn software.
  • Demonstrated ability in all modes of chromatography including column packing and buffer/solution preparation.
  • Experience in developing chromatography and filtration scale-down models for use in protocol driven process characterization and validation activities is desirable.
  • Experience in filtration including general operation as well as capacity determination.
  • Must be familiar with GMP guidance(s) and support clinical and commercial manufacturing with appropriately developed process.
  • Experience in viral clearance studies is desirable.
  • Experience with HPLC/UPLC; experience with electrophoretic, ELISA, and associated equipment is desirable.
  • Excellent communication skills in English, both verbal and written, and the ability to interface effectively with analytical, process, and business development is required.
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams.
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done.
  • An assertive, take-charge, scientist or engineer with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
  • The ability to listen to, learn about, and build upon organizational best practices and successes.
  • A competent, fast learning individual with the ability to multitask and adapt to change.
  • A mature thinking and acting scientist or engineer with good common sense and judgment.

  Location: Cranbury, NJ  (map)
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Job Description:

 

The Senior Engineer I/ II, Upstream Manufacturing Support, is a new position, created to provide strong leadership as Oncobiologics continues its rapid growth.  The Senior Engineer I/ II, Manufacturing Support, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center.

Qualifications and Experience:

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent
  • Minimum of 8-10 years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs
  • The applicant should have an in-depth knowledge in the principles of process scaling upstream processes from process development to clinical manufacturing, cell culture unit operations, as well as associated single-use technology
  • The applicant should have a working knowledge of equipment qualification and process validation including 21 CFR Part 11 compliance
  • Experience with development or manufacturing as it relates to biologics, biosimilars or comparability is a plus
  • Thorough understanding of basic statistical tools for process data analysis 
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

Job Responsibilities:

  • Ensure seamless and rapid technology transfers from Upstream Process Development through the review of upstream technology transfer protocols and participation on project development teams
  • Author, review, and/or approve documentation for upstream manufacturing processes, including but not limited to, master batch records, standard operating procedures, production bill of materials, process flow diagrams, and campaign summary reports
  • Troubleshooting/ investigation of upstream process non-conformances and deviations
  • Management of the Oncobiologics’ material specification process.  This includes review and approval of material specifications for completeness and accuracy.  Provide technical advice on raw material monographs to ensure compliance with applicable region’s compendia
  • Compilation of upstream process data from clinical batches to establish critical processing parameters and PAR
  • Review of RFP’s and URS’ for customized automation and integration of packaged systems such as single use bioreactors, chromatography systems, TFF systems, depth filtration systems
  • Execution of site VMP to ensure a constant state of compliance in a multi-product/ multi-phase manufacturing facility
  Location: Cranbury, NJ  (map)
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Job Description:

 

Opportunity and Summary of Position:

The Supervisor, Upstream Operations, will execute and supervise upstream manufacturing operations as Oncobiologics continues its rapid growth.  The Supervisor, Upstream Operations, will be required to execute and supervise cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position.

Position Responsibilities:

Upstream Supervisor, Upstream Operations, will report to the Group Leader, Upstream Operations with responsibilities including but not limited to:

  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance and oversight of Upstream cGMP Operations in accordance with Standard Operating Procedures (SOP’s); Master Batch Records (MBR’s); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, troubleshoots process issues, and remedies safety & maintenance issues with Area Management.
  • Provides review of executed documentation for completeness and accuracy and works with Quality Assurance to reconcile comments.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs, Deviations and Change Controls as directed by area management.
  • Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.
  • Mentor a staff of up to six (6) direct reports.

Qualifications and Skills

  • B.S. Life Sciences or equivalent
  • 6 + years progressive industry experience within an upstream biologics drug substance manufacturing environment.
  • Superior ability in cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs,
    • Aseptic technique
    • Cell culture
    • Bioreactor operations
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

Physical Requirements:

  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
  • Must have the ability to stand for long periods of time.
  • Works in production environment with exposure to latex and bleach.  Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors.  Following proper safety procedures minimizes potential for exposure.
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
View Description
Job Description:

 

Opportunity and Summary of Position:

The Supervisor, Downstream Operations, will execute and supervise downstream manufacturing operations as Oncobiologics continues its rapid growth.  The Supervisor, Downstream Operations, will be required to execute and supervise cGMP operations within the Biologics Manufacturing Center.  This is an exempt position.

 

Position Responsibilities:

Supervisor, Downstream Operations, will report to the Group Leader, Downstream Operations with responsibilities including but not limited to:

  • This position will work diligently to meet scheduled timelines, and will work as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance and oversight of Downstream cGMP Operations in accordance with Standard Operating Procedures (SOP’s); Master Batch Records (MBR’s); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, troubleshoots process issues, and remedies safety & maintenance issues with Area Management.
  • Provides review of executed documentation for completeness and accuracy and works with Quality Assurance to reconcile comments.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs, Deviations and Change Controls as directed by area management.
  • Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.
  • Mentor a staff of up to six (6) direct reports.

Qualifications and Skills

  • B.S. Life Sciences or equivalent
  • 6 + years progressive industry experience within a downstream biologics drug substance manufacturing environment.
  • Superior ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs
    • Chromatography 
    • Tangential flow filtration
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

 

Physical Requirements:

  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
  • Must have the ability to stand for long periods of time.
  • Works in production environment with exposure to latex and bleach.  Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors.  Following proper safety procedures minimizes potential for exposure.
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
View Description
Job Description:

Opportunity and Summary of Position:

The Operator I/II, Downstream Operations, will execute downstream manufacturing operations as Oncobiologics continues its rapid growth.  The Operator I/II, Downstream Operations, will be required to execute cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position.

Position Responsibilities:

  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance of Downstream cGMP Operations in accordance with Standard Operating Procedures (SOPs); Master Batch Records (MBRs); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs as directed by area management.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.

Qualifications and Skills:

  • B.S. Life Sciences or equivalent
  • 0 - 2 + years industry experience within a downstream biologics drug substance manufacturing environment.
  • Limited ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs preferred
    • Chromatography 
    • Tangential flow filtration
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

 

Physical Requirements:

  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
  • Must have the ability to stand for long periods of time.
  • Works in production environment with exposure to latex and bleach.  Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors.  Following proper safety procedures minimizes potential for exposure.
  • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
View Description
Job Description:

Opportunity and Summary of Position:

The Sr. Operator I/II, Downstream Operations, will execute downstream manufacturing operations as Oncobiologics continues its rapid growth.  The Sr. Operator I/II, Downstream Operations, will be required to execute cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position.

Position Responsibilities:

Sr. Operator I/II, Downstream Operations, will report to Supervisor, Downstream Operations with responsibilities including but not limited to:

  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance of Downstream cGMP Operations in accordance with Standard Operating Procedures (SOPs); Master Batch Records (MBRs); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately, and provides potential solutions.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs and Deviations as directed by area management.
  • Innovate technologies that embrace continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards/.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.

Qualifications and Skills:

  • B.S. Life Sciences or equivalent
  • 4 - 6+ years progressive industry experience within a downstream biologics drug substance manufacturing environment.
  • Demonstrated ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs, required
    • Chromatography 
    • Tangential flow filtration
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
View Description
Job Description:

 

Opportunity and Summary of Position:

The Operator I/II, Upstream Operations, will execute upstream manufacturing operations as Oncobiologics continues its rapid growth.  The Operator I/II, Upstream Operations, will be required to execute cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position

Position Responsibilities:

Operator I/II, Upstream Operations, will report to Supervisor, Upstream Operations.

  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance of Upstream cGMP Operations in accordance with Standard Operating Procedures (SOPs); Master Batch Records (MBRs); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs as directed by area management.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.

Qualifications and Skills:

 

  • B.S. Life Sciences or equivalent
  • 0 - 2 + years industry experience within an upstream biologics drug substance manufacturing environment.
  • Limited ability in cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs, preferred
    • Aseptic technique
    • Cell culture
    • Bioreactor operations
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

View Description
Job Description:

Opportunity and Summary of Position:

The Sr. Operator I/II, Upstream Operations, will execute upstream manufacturing operations as Oncobiologics continues its rapid growth.  The Sr. Operator I/II, Upstream Operations, will be required to execute cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position.

Position Responsibilities:

Sr. Operator I/II, Upstream Operations, will report to Supervisor, Upstream Operations.

 

  • This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule.  Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
  • Performance of Upstream cGMP Operations in accordance with Standard Operating Procedures (SOPs); Master Batch Records (MBRs); Equipment Qualification Protocols; and other applicable instructional documentation.
  • Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately, and provides potential solutions.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Participate in starting up facility and process equipment.
  • Reviews, revises and authors SOPs and Deviations as directed by area management.
  • Innovate technologies that embrace continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.

Qualifications and Skills:

 

  • B.S. Life Sciences or equivalent
  • 4 - 6 + years progressive industry experience within an upstream biologics drug substance manufacturing environment.
  • Demonstrated ability in cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs, required
    • Aseptic technique
    • Cell culture
    • Bioreactor operations
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done

  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

Overview

The Senior QA Specialist, Quality Systems will work with the QA Manager, Quality Systems to ensure that the organization is compliant with relevant cGMPs and assist with the implementation of continuous quality improvements.

 

Position Responsibilities

   Primary responsibilities:

  1. Support for Deviation, Investigation, and CAPA Quality Systems documentation and resolution.
  2. Manage the Internal Audit program, including scheduling, performing and follow up of Internal Audits.
  3. Data collection for Quality System metrics, including but not limited to Deviations, CAPA, Change Control, Validation and Qualification, Internal and External Audits, etc.
  4. Assist the QA Manager in Supplier and Contractor qualification, including supplier and contractor qualification status review for periodic requalification.  Occasional travel to conduct and/or support external audits may be required.

   Additional responsibilities include:

  1. Provide QA support for Quality Control activities, including internal auditing, calibration/qualification document review, and SOP/Test Method document revision.
  2. Assist the QA Manager in administration of the Change Control Quality System, including oversight of change control plans for compliance with target completion date.
  3. Development and implementation of QA procedures.
  4. Ensure compliance with relevant cGMPs and ensure readiness for global health authorities’ inspections.

 

Candidate Qualifications:

The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:

  Education/Certification

  • BS or MS in Sciences, or equivalent cGxP experience will be considered:  three (3) to five (5) years in Quality Assurance in the (bio)-pharmaceutical industry.
  • Certification(s) not required.

   Qualifications and Skills

  • Solid understanding of GMP regulations, CFR 21 Parts 210 and 211.
  • Organized, detail oriented, and can apply critical thinking to problem solving.  Proficient in Microsoft Office.
  • Ability to work independently with management oversight as needed.
  • Contributes to department goals.
  • Auditing experience is a plus.
  Location: Cranbury, NJ  (map)