Current Job Postings

CURRENT CAREER OPPORTUNITIES

To learn more, please click VIEW DESCRIPTION for any of the positions listed below. To apply for a position, click on the title of the job posting.

There are: 13 Job Openings at Oncobiologics Inc.

View Description
Job Description:

 

Qualifications and Experience:

MS or Ph.D. in Biotechnology or Life Science. Minimum 4+ years for MS/PhD; must have demonstrated ability to design and evaluate experiments; Excellent scientific understanding of biology and engineering principles for mammalian cell culture, including cell biology and metabolism, medium optimization, process development and scale-up. Flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement.

Position Responsibilities:

This position will directly report to the Head of Upstream Development with responsibilities including but not limited to:

Process Development 

  • Plan and execute experiments performed to evaluate cell lines, culture media, feeding strategies and process conditions.
  • Responsible for robust and optimized cell culture manufacturing processes that are developed for every mammalian cell line that has the potential to go into cGMP Manufacturing
  • Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate with others groups and clients as necessary
  • Motivated scientist to develop efficient and robust cell culture processes with high titer and product quality in support of the expanding Biosimilar pipeline.
  • They will work in a highly inter- disciplinary environment and provide technical oversight to junior colleagues.
  • Excellent scientific understanding of systems biology (e.g. -omics approaches and Metabolic Flux Analysis) and engineering principles for mammalian cell culture, including cell biology and metabolism, medium optimization, process development and scale-up.
  • Desire for mechanistic understanding of industrial bioprocess, a passion for scientific excellence, strong communication and collaboration skills, and capability to deliver complex objectives under aggressive timelines should apply for this position
  • Optimizing processes already in place to improve product yield
  • Knowledge of mammalian cell culture, media development, and primary recovery which they will be able to independently and proactively apply to the design and execution of process development experimentation, methods development and process improvement
  • Work in collaboration with Operations group to execute protocols, experimental plans, critical production batches, and tech transfers.
  • Use designed experiments (DOE) to predict/understand/control the impact of process parameters on product quality (CQAs) and production.
  • Media development and optimization based on cellular demand, productivity, and critical quality attributes
  • Represent functional area in team meetings as required.
  • Author experimental plans, reports, and operating procedures
  • Maintain a current laboratory notebook with scientific rigor to meet project needs for process development.
  • Work closely with the cell line development team to guide efforts toward scalable and robust culture processes.
  • Develop effective mammalian scale-down capabilities and implement effective and scalable process control strategies.
  • Follow standard operating procedures for laboratory duties, experiment design, data analysis and process monitoring
  • This position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position

Equipment and Facilities 

  • Participate in design and procurement of process equipment. Partner with vendors to deliver state of the art technologies.
  • Innovate technologies that enable the miniaturization of development systems and
  • increase the efficiency of process development
  • Develop efficient and innovative solutions to enable cGMP facility design and operation.
  • Follow full GMP guidance and fulfill all Quality Assurance requirements where required.
  • Operate safely and according to company environmental requirements.

Culture 

  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Present data or ideas in team meetings.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Head of Upstream Development may assign other responsibilities as required.
  • Provide mentoring, coaching, training to others.
  • Demonstrated technical leadership skills
  • Good oral and written communication skills
  • Must be able to work productively in an interdisciplinary team environment.
  Location: Cranbury, New Jersey  (map)
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Job Description:

 

Opportunity & Summary of Position:

The Senior Engineer I/ II, Equipment Qualification Manufacturing Support position provides a strong leadership as Oncobiologics continues its rapid growth.  The Senior Engineer I/ II, Equipment Qualification Manufacturing Support, will be responsible for introducing new equipment/systems and maintenance of validated system into the Biologics Manufacturing Center. 

Qualifications & Experience:

  •  B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent
  •  Minimum of 7-10 years of progressive industry experience with facility and equipment qualification in a startup environment
  • The applicant should have an in depth knowledge of equipment qualification, especially as it relates to single-use technology, including 21 CFR Part 11 compliance, and/or cleaning validation
  • Understanding of process validation requirements
  • Experience with development or manufacturing as it relates to biologics, biosimilars or comparability is a plus
  • Thorough understanding of basic statistical tools for 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
     

Position Responsibilities:

The Senior Engineer I/ II, Manufacturing Support, will report to the Senior Manager/ Group Leader, Manufacturing Support, with responsibilities including (but not limited to):

  • Creation 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

  • Evaluation of electronic systems to replace paper based systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance

  • Execution of site VMP to ensure a constant state of compliance in a multi-product/ multi-phase manufacturing facility.  Act as a main point of contact to validation contractors and manage equipment qualification program.

  • Author, review, and/or approve documentation in support of Oncobiologics Equipment qualification Program

  • Troubleshooting/ investigation of equipment related non-conformances and deviations

  • Ensure seamless and rapid technology transfers from Process Development through the review of technology transfer protocols and participation on project development teams in order to assess the facility fit of a process

  Location: Cranbury, New Jersey  (map)
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Job Description:
 
Qualifications & Experience:
 
  • BS, MS or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology or equivalent field.
  • A minimum 4 years of experience with M.S. or 6 years with B.S is required.
  • Excellent scientific understanding of assay development and validation for antibody/protein characterization.
  • Hands on experience on various liquid chromatography-mass spectrometry and liquid chromatography methods e.g. peptide mapping for sequencing, post-translational modification, N-linked and O-linked glycosylation characterization.
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and be flexible with changing project timeline.
  •  Familiarity with PepFinder, Protein Discoverer, Deconvolution, Pinpoint, Mascot, GPMAW.
  • Excellent written, oral communication and presentation expertise.
  • Effective teamwork with decision influencing and problem solving skills.
  • Highly-motivated. Highly-motivated. Ability to work effectively under pressure to meet deadlines.
 
Job Responsibilities:
 
  • Perform method development in glycan structure characterization, primary structure characterization (amino acid sequence, sequence variants, Intact mass, IdeS subunits, disulfide bond conformation, amino acid analysis, free thiol content), Post-Translational Modification (oxidation, deamidation, glycation, terminal variants etc.), peptide mapping identity, oxidation-UPLC.
  • Independently perform sample testing, data processing, data report and data interpretation for biosimilar development and stability studies, CQA assessment, similarity assessment and forced degradation.
  • Implement mass spec software tools as needed.
  • Prepare and review protocols, SOP and reports.
  • Maintain accurate and timely data records and documentation in ELN and logbooks.
  • Troubleshooting and solving instrument problems.
  • Provide training to junior scientists.
  • Write publication of scientific work.
  • Operate safely and according to company environmental requirements.
View Description
Job Description:

 

Opportunity and Summary of Position:

The Downstream Operations, Group Leader will execute and oversee all downstream operations as Oncobiologics continues its rapid growth.  The Downstream Operations, Group Leader, 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 aliquotting
    • Scheduling of all downsrtream 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)
View Description
Job Description:

 

Qualifications & Experience:

BS/MS or Ph.D. in Sciences or Engineering will be considered.  Ideal candidate would possess a comprehensive background in Sciences. 

Minimum 15 years of experience in biopharmaceutical industry with at least 10 years in QA.  Prior experience in providing QA support in a commercial setting is required. Prior experience with biological products is also required. Product release experience in a commercial setting is a plus. Experience working in a clinical manufacturing setting and implementing phase appropriate quality systems is an added plus.   Proven track record participating in Health inspections by global authorities is required.  Must have exceptional communication skills, both verbal and written, as well as excellent interpersonal skills.  Must be detail oriented, well organized and able to work independently as well as on teams.   

Job Description:

The Associate Director of Quality Assurance at Oncobiologics’ reports to the Director of Quality Assurance with responsibilities including (but not limited to):

  Quality Assurance

  • Responsible for the review and disposition of finished drug product to be used in clinical trials and ultimately for release of marketed products.
  • Conduct audits and provide oversight of Oncobiologics drug product contractors, raw material suppliers and contract laboratories.
  • Participate in the development of all quality systems required for commercial biologics manufacturing and release.
  • Responsible for recruitment and leadership of highly talented staff.
  • Review and approve all procedural documents from manufacturing and analytical testing.
  • Provide quality review of facility design and enable validation of both production equipment (mainly single-use technology) and analytical instrumentation.
  • Ensure that the organization is compliant with relevant cGMPs, lead internal audit teams and ensure readiness for global health authority inspections.

  Quality Assurance (other)

  • Implement risk management tools and techniques along with development and manufacturing.
  • Participate in Oncobiologics Quality Council which meets to discuss and resolve issues related to compliance.
  • Certain responsibilities of the QA Director will be delegated to other QA staff as the department grows.

  Culture

  • Support business development activities as required.
  • Support solutions for innovation and collaboration.
  • Develop customer relationships with peers.
  • QA Director may assign other responsibilities as required.
View Description
Job Description:

 

Qualification & Skills:

  • Ph.D./M.S. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology or equivalent field.
  • Minimum 2 - 4 years of pharmaceutical industry experience with antibody/protein characterization using various liquid chromatography-mass spectrometry and liquid chromatography methods e.g. peptide mapping for sequencing, 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 be flexible with changing project timeline.
  • Internal expert on data interpretation, applications and instrumentation.
  • Experience with personnel management and high performance team.
  • Excellent written, oral communication and presentation expertise.
  • Effective teamwork with decision influencing and problem solving skills.
  • Highly-motivated. Highly-motivated. Ability to work effectively under pressure to meet deadlines.

 

Job Responsibilities:

This position will directly report to the director of of Biophysical Characterization, Analytical Sciences with responsibilities including but not limited to:

  • 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, oxidation-UPLC, host cell protein using LC-MS.
  •    Lead the activities of method qualification and validation including preparation and review of protocols, SOP and reports.
  • Lead the sample analysis for biosimilar development and stability studies, CQA assessment, similarity assessment and forced degradation.
  • Works closely with Upstream and Downstream Process, Formulation andQC to ensure the results are communicated rapidly with high quality.
  • In collaboration with Analytical Development and Bioassay groups, develop techniques to isolate product variants and relate molecular structure to function.
  • Take a lead for troubleshooting of analytical issues.
  • Provide training to scientists.
  • Maintain accurate and timely data records and documentation in both ELN and paper systems.
  • Write publication of scientific work.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

Qualifications & Experience:

  • A Ph.D. in Biophysics, Biochemistry or equivalent filed with 2 - 4 years of industrial experience.
  • A MS in Biophysics, Biochemistry or equivalent filed minimum 10 years of experience.
  • In-depth understanding of biophysical characterization of proteins.
  • Strong understanding of biophysical method development and qualification.
  • Hands-on laboratory experience designing experiments with CD, FT-IR, MFI, AUC and DSC analysis for high order structure characterization and aggregation.
  • Experience characterizing the structural variants of monoclonal antibodies is preferred.
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and be flexible with changing project timeline.
  • Internal expert on data interpretation, applications and instrumentation.
  • Experience with personnel management and high performance team.
  • Excellent written, oral communication and presentation expertise.
  • Effective teamwork with decision influencing and problem solving skills.
  • Highly-motivated. Ability to work effectively under pressure to meet deadlines.

 

Job Responsibilities:

This position will report to the Director of Biophysical Characterization, Analytical Sciences with responsibilities including but not limited to:

  • Perform method development and sample testing in higher order structure characterization (CD, FT-IR, AUC, MFI, DSC) and protein folding (free thiol content, disulfide bond linkage).
  • Responsible for method qualification including preparation and review of SOPs, protocols and reports.
  • Collaborative interactions with Formulation, QC, CMB, Upstream and Downstream.
  • Work with CRO for outsourcing methods.
  • Develop and implement innovative, value-added assays/platforms to support similarity assessment.
  • Works closely with, and to ensure the results are communicated rapidly with high quality.
  • In collaboration with Analytical Development and Bioassay groups, develop techniques to isolate product variants and relate molecular structure to function.
  • Take a lead for troubleshooting of analytical issues.
  • Train, coach or mentor scientists.
  • Maintain accurate and timely data records and documentation in both ELN and paper systems.
  • Write publication of scientific work.
  Location: Cranbury, NJ  (map)
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Job Description:

 

Qualifications and Experience:

  •  Ph.D. /MS or BS in biology, cell biology, biochemistry or related field.
  •  Ph.D. with 0 – 2 years, M.S. with 4 to 6 years, and B.S. with 6 to 8 years of experience in developing cell based bioassays, and binding assays
  •  Firm knowledge of the biological principles behind mechanisms of drug action, cellular pathways and structure – function relationships
  • Knowledge of assay development principles and regulatory guidance for assay development, validation and data analysis
  • Experience in developing SPR based assays using the Biacore platform is highly desired
  • Knowledge of statistical analysis is highly desired
  • Proven track record of providing scientifically sound results while multitasking in a fast paced environment
  • Effective communication skills; Ability work in a team oriented environment
  • Experience in both research based and GMP environments

 

Responsibilities:

Develop and perform bioassays

  • Develop phase appropriate functional assays in multiple formats including cell based assays, ELISA and SPR binding assays, based on the knowledge of mechanisms of drug action and assay development principles
  • Possess/ gain a thorough understanding of regulatory guidelines of assay development and analysis
  • Provide bioassay support for release, stability, process development, formulation development and investigational studies
  • Maintain timely, detailed and accurate records of lab activities in ELN and logbooks as needed
  • Troubleshoot and maintain the equipment utilized within the department

Support publication and patenting of scientific work

  • Keep abreast with established and state-of-art science technology and scientific literature
  • Collaborate with internal and external resources to develop innovative and novel assay platforms
  • Participate in collaborative cross-departmental projects
  Location: Cranbury, NJ  (map)
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Job Description:

 

Oncobiologics is a rapidly growing, biopharmaceutical company focusing on development, manufacturing and commercialization of biosimilars. Located in central New Jersey, Oncobiologics has an immediate opening for a Scientist IV/Senior Scientist I - Biochemical Characterization.

Qualifications & Experience:

  • PhD/MS in Chemistry/Biochemistry or related field. Minimum 2 years of experience with PhD or 4 years of experience with MS in the Analytical or QC laboratories in pharmaceutical or biopharmaceutical companies.
  • Must have clear understanding of method development and method validation requirements under regulatory guidelines.
  • Must have demonstrated the ability to work independently with little supervision and be flexible with changing project timeline to support the process development and the manufacturing.
  • Experience in glycan analysis and familiarity with CMC and GMP are required.
  • Demonstrated solid understanding of the principles and practices of broad analytical technologies applicable to the analysis of biologics are desirable.  
  • Experience in the analysis of monoclonal antibody and the clear understanding of basic statistical analysis are desirable.
  • Excellent communication skills are required.

Job Responsibilities:

This position will directly report to Associate Director - Analytical Development with responsibilities including (but not limited to):

  1. Perform method development, method validation, and routine testing as needed to support cross-functional teams.
  2. Develop and validate the method for glycan analysis for monoclonal antibodies.
  3. Analyze in-process control samples, drug substances and drug products using technologies such as UV/VIS, CE-SDS, icIEF, SEC, CEX, HILIC, RP-HPLC, and Affinity Protein-A Chromatography.
  4. Operate the instruments and interpret analytical data using Empower, Chemstation, Astra, 32 Karat, 7500 SDS, etc., and present results to Process Development group.
  5. Lead junior scientists in Analytical Development to provide expertise in instrument maintenance and troubleshooting as well as resolution of OOS and OOT results.
  6. Keep real-time experiment records in ELN and prepare SOPs, protocols, technical reports to support the process development and regulatory filling.
  7. Assist Associate Director with purchasing of new equipment as needed.
  8. Contribute to departmental activities such as safety inspections and internal audits.
  9. Maintains tidiness in laboratory areas while following the safety guidelines provided by EHS.

Culture

  • Foster an interactive and cross-functional team work environment culture.
  • Follow best practices to reduce cost and meet budgetary requirements while maintaining quality.
  • Support business development and strategies.
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualifications and Experience:

  • BS/ MS in Biology, Cell biology, Biochemistry, Biotechnology or related field
  • 0 – 3 years of experience with MS and 2 – 6 years of experience with BS in performing functional assays including cell based assays, and binding assays
  • Hands on experience with cell culture, aseptic techniques, microscopy, and basic lab skills
  • Sound knowledge of cell biology and biochemistry. Conceptual understanding of the biological principles behind mechanisms of drug action
  • Familiarity with USP guidance for assay development, validation and data analysis is highly desired
  • Familiarity with SPR technology on Biacore is a plus
  • Experience with cGMP regulations is a plus
  • Motivation to be part of a high performance, efficient scientific team
  • Excellent spoken and written communication skills


Job Responsibilities:

Assist in the Development and Lifecycle management of Bioassays

  • Develop functional assays including cell based assays, ELISAs and other binding assays with minimum supervision
  • Independently maintain cell cultures, prepare reagents, and perform various bioassays
  • Possess, quickly gain an understanding of regulatory guidelines of assay design, and data analysis
  • Author SOPs and protocols with minimum supervision
  • Perform sample testing and provide results in a timely manner
  • Follow cGMP practices as necessary
  • Maintain accurate and detailed records of all lab activities
  • Maintain Bioassay lab and equipment
     
  Location: Cranbury, NJ  (map)
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Job Description:

 

Opportunity and Summary of Position:

The Manager, Logistics, will execute and oversee logistics operations as Oncobiologics continues its rapid growth. The Group Leader, Logistics, will be required to ensure cGMP compliant operations within the supporting areas of the Biologics Manufacturing Center (BMC).

 

Position Responsibilities:

  •  Lead a team of up to 3 FTEs responsible for the performance of logistics operations in support of biologics drug substance manufacturing to include:
    • Revise and maintain standard operating procedures in support of cGMP warehouse operations.
    • Scheduling of all downsrtream manufacturing activities and personnel
    • Formalize and manage shipment of materials domestically and internationally such as cell banks, and bulk drug substance at controlled temperatures.
    • Establish procedures for the import and export activities for international movement of materials and equipment in conjunction with customs & trade compliance.
    • Formalize and manage the receipt of cGMP and non-cGMP material such as raw materials, supplies and equipment.
    • Establish and maintain inventory control management that will monitor and maintain cGMP and non cGMP materials; perform cycle counts, perform inventory reconciliation during inventory discrepancy and staging of raw materials, consumables and supplies.
    • Execute the weigh and dispense functions in support of manufacturing operations.
  •  The qualified individual will need to:
    • Interface with manufacturing, quality assurance, quality control, and purchasing.
    • Support operational preparations through weigh and dispense and material fulfillment
    • Perform deviation investigation
    • Maintain cGMP documentation
    • Establish procedural and operational controls
    • Initiate, review, approve and facilitate change controls
    • Maintain a functional and compliant operations and warehouse area
    • Ensure that all equipment calibrations as well as preventive maintenance is scheduled
    • Present operational updates and data within group meetings as well as in departmental meetings as needed.
    • Maintain accurate documentation, compliant with cGMP guidelines.
    • Coach and mentor staff as needed
  • Management team may assign other responsibilities as required.

 

Qualification & Experience:

  • BA/BS Degree in Business or Science or Equivalent
  •  8-10 years of combined experience in shipping / warehouse operations; cGMP operations within the biopharmaceutical / biotechnology industry; weigh and dispense functionality.
  • Import/Export experience of Biologics
  • Experience developing cold chain solutions, such as shipping configurations for controlled ambient, 2-8°C, -20°C, and -80°C temperature controlled materials.
  • Hands-on experience within cGMP operations and cGMP inventory management controls at various scales.
  • Understand and apply cGMP principles to both Supply Chain and cGMP manufacturing
  • Experience with writing SOP’s and developing GMP documentation
  • Experience with cGMP facility start-up and subsequent qualification activities
  •  5 years leadership experience with junior staff
  • Clearance to drive company vehicles
  • Excellent oral and written communication skills
  • Will be required to drive a forklift and company provided truck

 

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)
View Description
Job Description:

 

Opportunity and Summary of Position:

Senior Scientist /Engineer, Purification Process Development, is a position that will support development of robust purification processes for biosimilar monoclonal antibodies and fusion proteins including chromatography and multiple types of filtration processes (e.g. depth, dead end, TFF, and nanofiltration). This position will support the Oncobiologics pipeline which spans early and late phase process development needs.  Senior Scientist /Engineer, 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.

Job Responsibilities:

  • Evaluation of chromatography resins and membrane adsorbers (e.g. Protein A, ion exchange, mixed mode, hydrophobic interaction) to be used in purification processes and process models.
  • Develop scalable chromatography methods that minimize types of buffers and maximize efficiency of operations in manufacturing.
  • Have core competency in filtration including methods for cell culture/fermentation clarification, depth filtration, tangential flow filtration, and viral clearance.  This should include working knowledge of filter capacity screening and evaluation.
  • Implement state of the art science and technology for screening chromatography resins and other separation techniques including automated liquid handling systems.
  • Maintain a current electronic laboratory notebook with scientific rigor to meet project needs for process development.
  • Provide input to associated in-process analytical strategies through the application of design of experiment for rapid speed to First in Human Studies.
  • Execute process development enabling analytics required to make development decisions rapidly.  Should have experience with HPLC/UPLC, electrophoretic, ELISA, and associated equipment.
  • Provide process support to functional areas as needed.
  • Represent purification development in team meetings as required.
  • Remain current with respect to chromatography techniques and equipment. Work to deliver state of the art technologies that innovate and are a differentiator for Oncobiologics.
  • Must be familiar with GMP guidance(s) and support Manufacturing with appropriately developed process including documentation of process knowledge.
  • Operate safely and according to company environmental requirements.
  • Author and review documentation, including but not limited to, technical transfer protocols and development reports.
  • Ensure seamless and rapid technology transfers to Clinical Manufacturing (in-house or outsourced partner) through technology transfer protocols and participation on project development teams.
  • 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 and who is willing to make a long-term commitment to the organization:

  • B.S/M.S/Ph.D Biochemistry, Chemistry, Chemical Engineering or equivalent field. 
  • Minimum 8+ years of experience in absence of graduate degree, 6+ years if MS, or 2+ years with PhD.
  • Have a working knowledge of purification instruments and their associated software (specifically GE Healthcare AKTA instruments and Unicorn software is a plus).
  • Demonstrated ability in all modes of chromatography including column packing and buffer/solution preparation.
  • Demonstrated ability in filtration principles and practice including general operation as well as capacity determination.
  • The applicant should have a working knowledge of the progression of “micro” scale purification development through confirmation of process at pilot scale.
  • The applicant should have a working knowledge of virus inactivation and small virus retention filtration.  Experience in viral clearance studies is a plus.
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development is required.
  • 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.
  • 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; however with 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 7-10 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 processesfrom 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)