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: 17 Job Openings at Oncobiologics Inc.

View Description
Job Description:

 

Qualifications & Experience:

  • BS or above in biology, cell biology, biochemistry or related field with experience in developing and performing in vitro functional assays. Job level will be commensurate with education and years of experience
  • Experience in one or more of the following is required
    • Developing cell based bioassays, immunoassays and/ or ligand binding assays
    • Assay development and sample testing on Biacore platform –  highly desired
    • Knowledge of statistical analysis
    • Sound knowledge of assay development principles and regulatory guidance for assay development, qualifcation/ validation design and data analysis
    • A good command over the biological principles behind mechanisms of drug action, cellular pathways and structure – function relationships
  • Must be able to multitask and work in a fast paced environment
  • Must be an effective communicator and team player
  • Experience in research and/ OR GxP environments

Responsibilities:

  Assist the Analytical Development Group in the development and performance of bioassays

  • Develop potency assays as well as functional characterization assays through deep knowledge of drug action mechanisms and assay development principles
  • Develop phase appropriate assays in multiple formats including, but not limited to cell based assays, ELISA based and receptor binding assays
  • Possess/ gain a thorough understanding of regulatory guidelines of assay design, development and analysis
  • Provide testing support for release, stability, process development, formulation development and investigational studies aimed at establishing structure-function correlation
  • Follow GMP compliant procedures including but not limited to timely, detailed and accurate documentation of lab activities and maintenance of the departmental equipment

  Support publication and patenting of scientific work

  • Keep abreast with established and state-of-art science technology and scientific literature to meet project needs for analytical sciences
  • Collaborate with internal and external resources to develop innovative and novel assay platforms.
  • Participate in collaborative cross-departmental projects for deeper understanding of mechanisms of action and structure-function correlations.

  Culture

  • Support business development activities as required
  • Support solutions for innovation and collaboration. Develop customer relationships with peers

 

  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

Qualification and Experience:

  • MS/BS in Chemistry/Biochemistry or related field. Minimum 2+ years of experience with MS or 4+ years of experience with BS in the Analytical or QC laboratories in pharmaceutical or biopharmaceutical industry.
  • 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.
  • Should have demonstrated the ability to produce excellent quality analytical results in a fast-paced team environment.
  • Experience in preparation of instrument SOPs and method SOPs are desirable.
  • Demonstrated hands-on experience in analytical testing such as chromatography and gel electrophoresis are desirable.
  • Demonstrated understanding of method development and method validation requirements under regulatory guidelines is desirable.
  • Familiarity with CMC and GMP requirements is desirable.
  • Excellent spoken and written communication skills are required.

Job Description:

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

  • Perform method development, method validation, and routine testing as needed to support process development and manufacturing.
  • Analyze in-process control samples, drug substances, and drug products using UV/VIS, CE-SDS, icIEF, SEC, CEX, Affinity Protein-A Chromatography, qPCR, and ELISA.
  • Operate the instruments and interpret analytical data using Empower, Chemstation, Astra, 32 Karat, 7500 SDS, etc., and present results to Process Development group.
  • Perform analysis to assist Senior Scientist to troubleshoot instrument performance issues or to resolve OOS and OOT results.
  • Keep real-time experiment records and prepare SOPs and reports as needed.
  • Contribute to departmental activities such as safety inspections and internal audits.
  • Maintains tidiness in laboratory areas while following the safety guidelines provided by EHS.

Culture:

  • Foster an interactive and multi-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:

 

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.

 

Position 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:

 

Qualification & Skills:

  • 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.

 

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 testingin 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)
View Description
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 in Analytical Development group.

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.

 

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:

 

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

Qualification & Experience:

  • B.S. Life Sciences or equivalent
  • 6+ years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated 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

 

Job Responsibilities:

  • This position will work diligently to meet scheduled timelines, and will work as required to meet production schedule.  Weekend, holiday and shift work may 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, process issues, and safety & maintenance issues to Area Management immediately.
  • Provides review of executed documentation for completeness and accuracy.
  • Creation and revision of cGMP documentation, including but not limited to MBR’s, SOP’s, etc. under QRM (Quality Risk Management) philosophies.
  • Participate in starting up facility and process equipment.
  • 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.

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.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

Qualification and Experience:

BS/MS or PhD 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. 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 Responsibilities:

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.
  • 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.

 

  Company 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.
  Location: Cranbury, NJ  (map)
View Description
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 I-II in Analytical Development group.

 

Qualification:

  • MS/BS in Chemistry/Biochemistry or related field. Minimum 1 years of experience with MS or 2 years of experience with BS in Analytical or QC laboratories in pharmaceutical or biopharmaceutical companies.  
  • 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.
  • Should have demonstrated the ability to produce excellent quality analytical results in a fast-paced team environment.
  • Demonstrated hands-on experience in analytical testing such as chromatography and gel electrophoresis are desirable.
  • Demonstrated understanding of method development and method validation requirements under regulatory guidelines is desirable
  • Experience in preparation of instrument SOPs and method SOPs is desirable.
  • Familiarity with CMC and GMP requirements is desirable.
  • Experience in Analytical R&D for biologics analysis is a plus.
  • Excellent communication skills are required.

 

This position will directly report to Senior Scientist II - Analytical Development with responsibilities including (but not limited to):

  1. Analyze in-process control samples, drug substances, and drug products using UV/VIS, HPLC (SEC, CEX, Protein A Chromatography), CE-SDS, and icIEF.
  2. Operate the instruments and interpret analytical data using Empower, ChemStation, Astra, 32 Karat, 7500 SDS, etc., and present results to Process Development group.
  3. Perform method development, method validation, and routine testing as needed to support process development and manufacturing.
  4. Perform analysis to assist Senior Scientist to troubleshoot instrument performance issues or to resolve OOS and OOT results.
  5. Keep real-time experiment records in ELN and prepare SOPs and reports as needed.
  6. Contribute to departmental activities such as safety inspections and internal audits.
  7. 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, 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.

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).

 

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:

  • 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)
View Description
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

Position 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)
View Description
Job Description:

 

Qualification 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.

Job Responsibilities:

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

Process Development (60%)

  • 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 (20%)

  • 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 (20%)

  • 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)
View Description
Job Description:

 

Qualifications & Experience
A BS/MS degree with a minimum of 3/5 years hands-on experience in antibody/protein analyses with various liquid chromatography, liquid chromatography-mass spectrometry methods and protein purification techniques. Must have strong interpersonal skills and the desire to work in a high pace biotech environment.

  • A strong working knowledge and experience with common modes of chromatographic separation such as reversed-phase, ion-exchange, hydrophobic/hydrophilic interaction chromatography, affinity and size exclusion.
  • Hands on experience on sample preparation for peptide mapping, intact mAbs molecular weight, N-glycosylation and etc.
  • A basic understanding of protein chemistry, Post Translational Modifications and degradation pathways.
  • Familiar to software Xcalibur, Proteome Discoverer, Promass, Empower for data acquisition and data processing, and data reporting.
  • Interact with other departments to provide support. Excellent communication skills, both written and oral.
  • Must be able to work in a fast pace environment, multi task and effectively interact within a team environment.
  • Familiarity and exposure to FDA, ICH and GLP, GMP regulations and guidelines.
  • Maintain accurate/on-time laboratory notebooks and relevant documentation.
  • Desirable Skills and Experience: Experience with UV-Vis spectroscopy, fluorescence spectroscopy, light scattering, calorimetry, particle size, DSC, DLS, MALS, TFF, electrophoresis (CE, IEF, SDS-PAGE, Western blot) and similar techniques for Secondary and Higher Order Structural Characterization.

 

Job Description

  • This position is within the Protein Characterization group of Development and Discovery Sciences, which is responsible for antibody/protein primary structure characterization, post translational modifications characterization,glycosylation characterization to assist the Analytical group, Formulation group, Discovery group, and bio-process department for a range of therapeutic proteins, including monoclonal antibodies and novel protein formats.
  • Seeking an innovative and motivated hands-on working professional who exhibits a broad analytical aptitude and can function in a highly collaborative multidisciplinary team environment to perform characterization of antibody/protein using Orbitrap and UPLC based techniques.
  • The successful candidate will develop, utilize, and troubleshoot UPLC/MS and UPLC assays, qualification of assays, transfer assays to Analytical/quality labs, documentation, collection and purification of variants.
     
  Location: Cranbury, NJ  (map)
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Job Description:

 

Qualification & Experience:

High school, Associates degree or equivalent experience in absence of degree.

 

Job Description:

The operations associate will be responsible for performing a wide variety of lab maintenance, glass washing, sonication, and autoclaving. Distribution to appropriate locations within the laboratories. Other duties include bioreactor assembly, solution/media preparations, ordering of laboratory supplies, and performs other related duties as required.

This position will have varying degree of oversight and independence based on level with responsibilities including but not limited to:

Process Operations (70%)

  • Participate in facility and equipment commissioning, routine operation, and in collaboration with maintenance, keep equipment in excellent working order.
  • Assembly and disassembly of bioreactors.
  • Operate glass washer, sonicator and autoclave.
  • Collecting, sonication, wash, and sterilization of glassware and distributing it to the appropriate locations within laboratories.
  • Routine cleaning of laboratory biosafety cabinets and incubators.
  • Minimally assist in lab experiments and document in electronic lab notebook system.
  • Maintain and order laboratory consumable, chemicals, cleaning supplies, etc.
  • Prepare analytical reagents, media and solutions required for process development and document in electronic lab notebook system.
  • Fulfill safety requirements and identify and mitigate risk for Lab and ensure compliance to safety. 
  • Change out of Liquid Nitrogen dewars, CO2, and O2 tanks as needed. 
  • Ability to follow SOPs.
     

cGMP Facility & Operations (10%)

  • Follow full GMP guidance and fulfill all Quality Assurance requirements as required.
  • Operate safely and according to company environmental requirements at all times.

Culture (10%)

  • Evaluate technologies and propose ideas for innovation.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Operations Manager may assign other responsibilities as required.
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualifications & Experience:  

  • B.S. Life Sciences or equivalent
  • 4+ years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated 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

 

 

Job Responsibilities:

The Upstream Scientist (Operator) III, Manufacturing, will execute upstream manufacturing operations as Oncobiologics continues its rapid growth.  The Upstream Scientist (Operator) III, Manufacturing, will be required to execute cGMP operations within the Biologics Manufacturing Center.    This position will report directly to the Upstream Team Lead (Supervisor), Manufacturing, 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 may be required based on manufacturing schedule as determined by Area Management.
  • Performance 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, process issues, and safety & maintenance issues to Area Management immediately.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Creation and revision of cGMP documentation, including but not limited to MBR’s, SOP’s, etc. under QRM (Quality Risk Management) philosophies.
  • Participate in starting up facility and process equipment.
  • 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.

 

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

 

The Manufacturing, Group Leader a new position created to execute and oversee manufacturing operations as Oncobiologics continues its rapid growth.  The Manufacturing, Group Leader, will be required to ensure cGMP compliant operations occur within the Biologics Manufacturing Center. This position will report to the Director of Manufacturing.

Qualifications & Experience:

  • MS/BS Degree in Life Sciences or Engineering discipline.
  • Minimum of 8+ years progressive industry experience of biologics drug substance manufacturing.  Preference will be given to candidates with commercial manufacturing experience
  • Minimum of 5+ years of supervisory experience in a biologics drug substance manufacturing operation
  • 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
  • Will be required to drive a forklift and company provided truck

Responsibilities:

Primary Duties

  • Lead a team of up to 25 FTEs (5 direct and 20 indirect) responsible for the manufacture of bulk drug substance to support Oncobiologics Clinical and Commercial needs.
    • Upstream and downstream manufacturing oversight
    • Scheduling of manufacturing activities
  • 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 upstream and downstream manufacturing
  • Serves as a member of a group that is responsible for the selection and implementation of an ERP system
  • Serves as a member of a group that is responsible for the construction, commissioning and qualification of a 15,000 ft2 expansion to increase production capacity
  • Coordination with cross functional areas to ensure that the manufacturing schedule is met
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Serves as mentor to Team Leads and Scientists 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.

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).
  • Foster a strong cross departmental team interactive culture.
  • Support business development and strategies activities as required.
  • Support solutions for new innovation and collaboration with peersin ONS departments.
  • Follow all company best practices to minimize cost and meet budgetary requirements while maintaining commitment to quality.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

The Downstream Scientist (Operator) I to IV, Manufacturing, will execute downstream manufacturing operations as Oncobiologics continues its rapid growth.  The Downstream Scientist (Operator) I to IV, Manufacturing, will be required to execute cGMP operations within the Biologics Manufacturing Center.  This is a non-exempt position.  This position will report to Downstream Team Lead (Supervisor), Manufacturing.

Qualifications and Experience

  • B.S. Life Sciences or equivalent
  • 0 – 6+ years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical 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

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 may be required based on manufacturing schedule as determined by Area Management.
  • Performance 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, process issues, and safety & maintenance issues to Area Management immediately.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Creation and revision of cGMP documentation, including but not limited to MBR’s, SOP’s, etc. under QRM (Quality Risk Management) philosophies.
  • Participate in starting up facility and process equipment.
  • 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.

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:

 

The Upstream Scientist (Operator) I to IV, Clinical Manufacturing, is a new position created to execute upstream manufacturing operations as Oncobiologics continues its rapid growth.  The Upstream Scientist (Operator) I to IV, Clinical Manufacturing, will be required to execute cGMP operations withing the Biologics Manufacturing Center.  This is a non-exempt position.  This position will report to Upstream Team Lead, Clinical Manufacturing.

Qualifications and Experience

  • B.S. Life Sciences or equivalent
  • 0 – 6+ 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
    • 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
  •  

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 may be required based on manufacturing schedule as determined by Area Management.
  • Performance 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, process issues, and safety & maintenance issues to Area Management immediately.
  • Provides initial review of executed documentation for completeness and accuracy.
  • Creation and revision of cGMP documentation, including but not limited to MBR’s, SOP’s, etc. under QRM (Quality Risk Management) philosophies.
  • Participate in starting up facility and process equipment.
  • 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.

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).


 

  Location: Cranbury, NJ  (map)