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: 18 Job Openings at Oncobiologics Inc.

View Description
Job Description:

 

Job Description:

Principal Scientist, Bioassay Development, will be responsible for the development, qualification, validation and technical transfer of robust biological test methods for biosimilar monoclonal antibodies.  Methodologies include, but are not limited to proliferation inhibition assays, reporter gene assays, immune mediated cytotoxicity assays, binding assays and flow cytometry.  Principal Scientist, Bioassay Development, will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.

Qualification & Skills:

  • M.S. or Ph.D. in Cell Biology, Life Sciences or equivalent
  • Minimum of 10 years progressive industry experience with biologics including late stage biological assay development and validation
  • Experience in authoring a BLA/MAA which resulted in approval and marketed product support
  • Experience with statistical methodologies such as DOE, analytical method performance trending, multivariate analysis
  • Experience with mammalian cell techniques and be able to maintain multiple cell cultures and cell line types
  • Experience with multiple assay platforms such as cell based assays, ELISA, SPR etc.
  • Experience with Forte Bio Octet, Biacore and FACS
  • Experience with CRO/CMO evaluation and analytical method transfer especially with respect to biological assays
  • Support the continuous improvement of quality systems required for the release and stability testing of biologics
  • Strong understanding of Quality by Design and Risk Management
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
  • Due to international nature of the tasks, fluency in written and spoken English
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized and able to work independently and in teams
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  •  
  • Well-organized and accustomed to changing priorities and maintaining excellent records

Responsibilities:

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

  • Serve as bioassay subject matter expert for all bioassay related activities, including risk assessments, characterization, investigations, regulatory interactions, and project team.
  • Develop, implement and execute the required biological assays to enable the robust characterization of biosimilar monoclonal antibodies.  Methodologies include, but are not limited to, immunoassays, receptor assays, ligand-binding assays, cell-based assays and  potency methods as well as methods that monitor biologics activity
  • Support process development enabling activities including in-process testing, drug substance, drug product, extended characterization and comparability.
  • Support the established regulatory plan with respect to compliance with FDA/EMA/ROW.
  • Champion the bioassay group’s effort to maintain focus on established technologies while continuing to evaluate and implement where appropriate, cutting edge technologies.
  • Lead the bioassay discipline with excellent scientific and critical rigor and technical writing.
  • Develop, qualify and validate required methods to global regulatory standards.
  • Collaborates and communicates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
  • Evaluate opportunities for improving robustness of existing biological methods.
  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions.
  • Build department of scientific excellence to enable prosecution of mAb biosimilar pipeline.
  • Represent the Company before EU and FDA regulatory authorities.
  Location: Cranbury, New Jersey  (map)
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Job Description:

Overview

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

Qualifications:

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

 

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

Responsibilities:

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

 

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

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

 

Opportunity & Summary of Position:

The Downstream Sr. Engineer MTS, is a position created to provide strong leadership as Oncobiologics continues its rapid growth.  The Process Engineer MTS, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center. The Downstream Sr. Engineer MTS, will report to the Director, Manufacturing Technical Support.

Qualifications & Experience:

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent
  • Minimum of 5 years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical cGMP bioprocess operations, particularly of mammalian expressed mAbs
  • Thorough understanding of downstream related equipment and processes, including chromatography, TFF, viral inactivation, viral filtration, and Drug Substance fill
  • The applicant should have an in-depth knowledge in the principles of scaling processes development to clinical manufacturing
  • The applicant should have a working knowledge of equipment qualification and process validation including 21 CFR Part 11 compliance
  • The applicant should have working knowledge of single use technology
  • 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
  • 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 Downstream Process Development through the review of technology transfer protocols and participation on project development teams
  • Author, review, and/or approve documentation for downstream manufacturing processes, including but not limited to, master batch records, standard operating procedures, production bill of materials, process flow diagrams, and campaign summary reports
  • Provide technical expertise in support of downstream investigations for process deviations
  • Management of the Oncobiologics’ material specification process.  This includes review and approval of material specifications for completeness and accuracy.  
  • Compilation of downstream process data from clinical batches to establish critical processing parameters and PAR
  • Review of RFP’s and URS’ for customized automation and integration of systems such as single use technology, 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, New Jersey  (map)
View Description
Job Description:
Overview:

Biophysical Characterization group is responsible for the development, qualification, validation and technical transfer of robust physicochemical test methods for biosimilar monoclonal antibodies, and sample testing to support biosimilarity assessment and formulation/process development.  Methodologies include but are not limited to DSC,CD, FT-IR, HIAC, MFI, AUC, HPLC and mass spectrometry.  She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.

 
Qualifications & Experience:

 

  • B.S. or M.S. in Chemistry, Pharmaceutical Sciences, Biochemistry or equivalent life science
  • Minimum of 6 years of experience in the biopharmaceutical industry with antibody/protein characterization using various technologies for higher order structure characterization and aggregates/particulates analysis e.g. DSC,CD, FT-IR, HIAC, MFI and AUC
  • Experience with HPLC and mass spectrometry is desirable
  • A clear understanding of analytical method development, qualification, validation
  • Internal expert on data interpretation, applications and instrumentation and the theory in protein higher order structure
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams
  • Support the continuous improvement of data quality systems required for the stability testing and regulatory filing
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with functional groups
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records
 
Job Responsibilities:

 

  • Perform method development in secondary, tertiary structure characterization (DSC, CD, FT-IR), aggregation and particulates analysis (AUC, HIAC, MFI) and primary structure characterization(peptide mapping identity-UPLC, glycan profiles-UPLC,free thiol content, amino acid sequence, sequence variants, Intact mass, IdeS subunits, disulfide bond conformation and post-translational modifications)
  • Design and conduct method validation and method transfer including preparation and review of protocols, SOPs and reports
  • Conduct sample analysis efficiently for formulation development, process development, CQA assessment, similarity assessment, stability studies, and forced degradation studies
  • Take a lead in troubleshooting of analytical challenges
  • Provide training to junior scientists
  • Maintain accurate and timely data records and documentation in both ELN and paper systems
  • Operate safely and according to company environmental requirements

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

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

Qualifications & Experience:

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

Job Description:

 

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

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

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

Opportunity and Summary of Position:

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

Position Responsibilities:

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

Qualifications & Experience:

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

 

Position Summary:

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

Qualification & Skills:

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

Job Responsibilities:

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

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

Job Description:

Biophysical Characterization group is responsible for the development, qualification, validation and technical transfer of robust biophysical test methods for biosimilar monoclonal antibodies, and the sample testing to support biosimilarity assessment and formulation/process development.  Methodologies include but are not limited to DSC,CD, FT-IR, HIAC, MFI, AUC, HPLC and mass spectrometry.  She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development and characterization of biosimilars in all stages of development.

Qualifications & Experience:

  • M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or equivalent life science
  • PhD with minimum 2 - 4 years of experience or MS with minimum of 6-8 years of experience in the pharmaceutical industry with antibody/protein characterization using various technologies for higher order structure characterization and aggregates/particulates analysis e.g. DSC,CD, FT-IR, HIAC, MFI and AUC
  • Experience with biosimilar development is a plus
  • In-depth understanding of analytical method development, qualification, validation
  • Internal expert on data interpretation, applications and instrumentation and the theory in protein higher order structure
  • Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams
  • Support the continuous improvement of data quality systems required for the stability testing and filing
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with functional groups
  • A “hands-on” energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
  • Well-organized and accustomed to changing priorities and maintaining excellent records

 

Job Responsibilities:

This position will report to the Director, Biophysical Characterization and Analytical Science.

  • Take a lead in method development in secondary, tertiary structure characterization (DSC, CD, FT-IR), aggregation and particulates analysis (AUC, HIAC, MFI) and primary structure characterization(peptide mapping identity-UPLC, glycan profiles-UPLC,extinction coefficient, free thiol content, amino acid sequence, sequence variants, Intact mass, IdeS subunits, disulfide bond conformation and post-translational modifications)
  • Lead the activities of method qualification and validation including preparation and review of protocols, SOPs and reports
  • Lead the sample analysis for formulation development, process development, CQA assessment, similarity assessment, stability studies, and forced degradation studies
  • Take a lead for troubleshooting of analytical challenges when they arise
  • Develop and implement innovative, value-added assays/platforms to support similarity assessment
  • Provide training to junior scientists
  • Maintain accurate and timely data records and documentation in both ELN and paper systems
  • Operate safely according to company requirements and take a lead in lab inspection
  • Author or participate in peer reviewed publication of scientific work as well as patent applications when appropriate


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

Overview:

Oncobiologics has an immediate opening for Sr. Scientist I/II in Biochemical Assay Development.  The group supports the process development of monoclonal antibody therapeutics.  The main mission of the group is the development and validation of physicochemical methodologies and process-related impurity assays.  As part of this overall goal, the candidate would be required to perform routine and non-routine testing, perform the method development and validation of the physicochemical test methods, and create and execute experimental plan which assess the physicochemical stability of biological drug candidates.  This includes generating, documenting, and analyzing data for discussions and technical reports.  Sr. Scientist I/II will also be responsible for CMC development support. This position will report to Director of Biochemical & Bioassay Development.

 

Qualifications and Experience:

  • MS or PhD in Chemistry or related subject area.
  • Minimum 6 years with MS or 4 years with PhD experience in Analytical or QC laboratories in pharmaceutical or biopharmaceutical industry.
  • Must have clear understanding of method development and validation under regulatory guidelines.
  • Must have demonstrated the ability to work independently with little supervision and be flexible with changing project timeline.
  • Solid understanding of the principles and practices of analytical technologies applicable to the biological drug products are required. 
  • Experience in the analysis of monoclonal antibody therapeutics and the basic statistical analysis are highly desirable. 
  • Familiarity with CMC and GLP/GMP requirements is desirable.
  • Hands-on experience on the following methodologies: CE-SDS, CEX-HPLC, ELISA, rHCP, HILIC, cIEF, Protein-A HPLC, qPCR, rProtein A, rDNA, SE-HPLC, and SE-UPLC.
  • An ability to effectively and collaboratively participate in team discussions (e.g., communication of test results, OOT results, scientific principles).
  • An ability to prepare clearly written documents (e.g., SOPs, test methods, protocols, technical reports, method validation reports).
  • Excellent verbal and written communication skills.

 

Responsibilities:

  • Perform method development and validation.
  • Perform routine and non-routine testing to support the process development using the instruments such as spectrophotometer, capillary electrophoresis (CE-SDS, cIEF), chromatography (HPLC/UPLC), SEC-MALS, plate reader (ELISA), and qPCR.  
  • Lead junior scientists in the group to provide expertise in technical supports and instrument maintenance and troubleshooting.
  • Support Quality Control for resolution of OOS and OOT results.
  • Maintain the tidiness in the laboratory while following the safety guidelines provided by EHS.
  • Keep real-time experiment records in ELN and prepare documents (SOP, protocol, report).
  • Contribute to the departmental activities such as new instrument purchasing, laboratory safety inspections, and internal audits.
  • Analyze in-process control samples, drug substances, and drug products.
  • Performs data review to ensure accuracy, completeness, and validity.
  • Performs routine lab inspections.
  • Participates in safety inspections, internal audits, and regulatory inspections.
  • Support CMC development of monoclonal antibody therapeutics.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

Job Description:

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

Qualifications & Experience:

 

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

Job Responsibilities:

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

Overview:

Oncobiologics has an immediate opening for Scientist I/II in Bioassay Development.  The group supports the release and stability testing of monoclonal antibody therapeutics.  The main mission of the group is the development and qualification/validation of bioassays to support the drug development.  As part of this overall goal, the candidate would be required to perform routine and non-routine testing, assist in the method development and qualification/validation of the bioassays, and creation and execution of experimental plan which assess the functional characteristics of biological drug candidates.  This includes generating, documenting, and analyzing data for discussions and technical reports.

 

Qualifications and Experience:

  • MS or BS in Biology, Cell Biology, Biochemistry or related field
  • Minimum 1 year with MS or 3 years with BS of industry experience in the Bioassay laboratories in biotechnology or biopharmaceutical industry.
  • Hands-on experience in cell based assays, ELISA binding assays, and SPR based assays (Biacore, Octet) are desirable.
  • A thorough understanding of cell culture technique is desirable.
  • Basic understanding of statistical data analysis and familiarity with Softmax and Parallel-Line Analysis (PLA) software is desirable.
  • An ability to effectively present the test procedures and test results in the team discussions.
  • An ability to prepare clearly written documents (e.g., SOPs, test results summary).
  • An ability to work independently with little supervision and be flexible with changing project timeline to support the process development.
  • Experience in the analysis of monoclonal antibody or the late stage biologics support is desirable.
  • Familiarity with GLP/GMP is desirable.
  • Excellent verbal and written communication skills.


Job Responsibilities:

  • Perform routine and non-routine potency assays, functional assays, and effector function assays such as ADCC and CDC to support the process development of monoclonal antibody therapeutics.
  • Assist in development, qualification, validation, and transfer bioassays.
  • Establish proper cell culture techniques, prepare reagents, and maintain appropriate cell lines for each project.
  • Assist in maintenance and troubleshooting of laboratory instruments. 
  • Keep real-time experiment records in ELN.
  • Contribute to departmental activities such as safety inspections and internal audits.
  • Assist in non-routine testing to support Quality Control for OOS/OOT investigation.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

Overview:

Oncobiologics has an immediate opening for Scientist III/IV in Bioassay Development.  The group supports the release and stability testing of monoclonal antibody therapeutics.  The main mission of the group is the development and qualification/validation of bioassays to support the drug development.  As part of this overall goal, the candidate would be required to perform routine and non-routine testing, assist in the method development and qualification/validation of the bioassays, and creation and execution of experimental plan which assess the functional characteristics of biological drug candidates.  This includes routine and non-routine testing, generating, documenting, and analyzing data for discussions and technical reports.

Qualifications & Experience:

 

  • MS/BS in Biology/Cell Biology/Biochemistry or related field (MS preferred)
  • Minimum 2 years (MS) or 5 years (BS) of progressive industry experience in the Bioassay laboratories in biotechnology or biopharmaceutical industry.
  • Hands-on experience in cell based assays, ELISA binding assays, and SPR based assays (Biacore, Octet).
  • A thorough understanding of cell culture technique is required.
  • Basic understanding of statistical data analysis and familiarity with Softmax and Parallel-Line Analysis (PLA) software is desirable.
  • An ability to effectively and collaboratively participate in team discussions (e.g., communication of test results, OOT results, scientific principles).
  • An ability to prepare clearly written documents (e.g., SOPs, technical reports, method qualification/validation reports).
  • Excellent verbal and written communication skills.
  • An ability to work independently with little supervision and be flexible with changing project timeline to support the process development.
  • Experience in the analysis of monoclonal antibody or the late stage biologics support is desirable.
  • Familiarity with CMC and GMP is desirable. 

Job Responsibilities:

  • Perform routine and non-routine potency assays, functional assays, and effector function assays such as ADCC and CDC to support the process development of monoclonal antibody therapeutics.

  • Develop, qualify/validate, and transfer bioassays.

  • Establish proper cell culture techniques, prepare reagents, and maintain appropriate cell lines for each project.

  • Train junior scientists and maintain/troubleshoot laboratory instruments.

  • Keep real-time experiment records in ELN and prepare SOPs and reports.

  • Contribute to departmental activities such as safety inspections and internal audits.

  • Provide technical supports to QC for OOS/OOT investigation.

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

 

Opportunity and Summary of Position:

The MTS Director will be expected to provide strong leadership as Oncobiologics continues its rapid growth.  The Director, MTS, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center, including Tech Transfer and scale-up technical support.  The MTS Director will report to the Vice President of Manufacturing.

 

Position Responsibilities:

 

  • Lead a multi-disciplined group responsible for process engineering, equipment qualification, tech transfer, and process scale-up
  • Manage creation of RFP’s and URS’ for customized automation and integration of packaged systems such as single use bioreactors and upstream equipment, chromatography systems, TFF systems, and depth filtration systems
  • Lead evaluation of electronic systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance
  • Manage Execution of site VMP to ensure a constant state of compliance in a multi-product/ multi-phase Manufacturing facility
  • Manage coordination of equipment qualification and validation program
  • Manage drafting, review, and/or approval of documentation, including but not limited to validation/qualification protocols, master batch records, standard operating procedures, production bill of materials, process flow diagrams, sampling plans, and campaign summary reports
  • Manage troubleshooting of all equipment and processes
  • Manage investigations of process and equipment related deviations
  • Serve as the MTS representative on the Change Control Review Committee and other committees and task forces as assigned by the Vice President, Manufacturing
  • Ensure seamless and rapid technology transfers from Process Development to Manufacturing
  • Team with PD to draft and review/approve technology transfer protocols
  • Lead and/or support activities in participation on project development teams
  • Provide technical support to Quality for 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 process data from clinical batches to establish critical processing parameters and PAR
  • Team with PD to lead data review meetings and provide data analysis

 

Qualification & Experience:

 

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent
  • Minimum of 8 years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical cGMP bioprocess operations, particularly processes of mammalian expressed glycoproteins, mAbs, or ERTs
  • In-depth knowledge in the principles of process scaling from process development to clinical manufacturing to commercial manufacturing
  • In-depth knowledge of single-use technology
  • Working knowledge of equipment qualification and process validation including 21 CFR Part 11 compliance
  • Experience with development or manufacturing as it relates to biosimilars is a plus
  • Excellent communication skills, both verbal and written
  • Ability to interface effectively with analytical, process, business development, manufacturing, sales and marketing, and administration departments
  • 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, proven leader with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done; however with the ability to listen, learn about, and build upon organizational best practices and successes
  • A mature thinking and acting leader with good common sense and judgment, and a broad business perspective to build, motivate, and manage a strong MTS organization
  • A solid people manager who can also serve as a team mentor and staff developer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Location: Cranbury, NJ  (map)
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Job Description:

Opportunity and Summary of Position:

The Associate Director, Drug Product Manufacturing  will be expected to provide strong leadership as Oncobiologics continues its rapid growth.  The AD DP, Manufacturing, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center, including Tech Transfer and scale-up technical support. The DP Manufacturing Planning AD will report to the Vice President of Manufacturing.

Qualifications & Experience:

 

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent education/experience
  • Minimum of 8 years progressive industry experience in biologics and specifically with Drug Product manufacturing
  • Demonstrated ability in clinical and commercial GMP operations related to CMOs
  • Hands on experience in Drug Product manufacturing, filling, and labeling as appropriate
  • In-depth knowledge in the principles of regulatory requirements from clinical manufacturing to commercial manufacturing
  • Experience with building working relationships, as the client, with CMOs
  • Working knowledge of GMPs, and quality systems associated with CMOs
  • Working knowledge of drug product stability requirements
  • Project Management experience is preferred
  • Excellent communication skills, both verbal and written
  • 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, proven leader with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done; however with the ability to listen, learn about, and build upon organizational best practices and successes

Responsibilities:

 

  • Accountable for the global Drug Product Manufacturing production planning and scheduling through internal and CMO manufacturing resources
  • Lead the CMO relationships for clinical and commercial Drug Product Manufacturing
  • Utilize Manufacturing resources (internal or CMO) to deliver production requirements of drug product within timelines 
  • Build and lead a high performing production team as applicable, engaged in the DP Manufacturing and DP Project teams
  • Collaborate with QA, Project Management, and Planning and Logistics to ensure timely scheduling of Drug Product manufacturing
  • Serve as person-in-plant for drug product runs
  • Coordinate batch record review with QA to ensure on time approval of CMO documents
  • Partner with QA to ensure efficient management of all quality systems (deviations, change controls, CAPAs, etc.) in support of Drug Product release
  • Work closely with CMC team to provide support for regulatory filings
  • Create universal metrics in order to measure performance of CMOs, trend KPIs, and generate improvements plans as needed

  Location: Cranbury, NJ  (map)
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Job Description:

Overview:

 

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

 

Qualifications & Experience:

 

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

 

Job Responsibilities:

 

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

 

Opportunity and Summary of Position:

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

Job Responsibilities:

 

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

Qualifications & Experience:

The company is seeking an individual with the following qualifications:

 

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

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

 

The Process Engineer - MTS, is a new position, created to provide strong technical as Oncobiologics continues its rapid growth.  The Process Engineer, MTS, 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 3-5 years progressive industry experience with biologics drug substance scale-up and manufacturing
  • Demonstrated ability in clinical cGMP bioprocess operations, particularly of mammalian expressed mAbs
  • The applicant should have an in-depth knowledge in the principles of scaling processes from process development to clinical manufacturing
  • The applicant should have working knowledge of 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
  • 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 Process Development through the review of technology transfer protocols and participation on project development teams
  • Author, review, and/or approve documentation for manufacturing processes, including but not limited to, master batch records, standard operating procedures, production bill of materials, process flow diagrams, and campaign summary reports
  • Provide technical expertise in support of investigations for process deviations
  • Management of the Oncobiologics’ material specification process.  This includes review and approval of material specifications for completeness and accuracy.  
  • Compilation of 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:

 

Opportunity and Summary of Position:

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

Position Responsibilities:

Upstream Supervisor, Upstream Operations, will report to the Senior Manager, Upstream Operations with responsibilities including but not limited to:

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

Qualifications and Skills

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

Physical Requirements:

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