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: 20 Job Openings at Oncobiologics Inc.

View Description
Job Description:

 

Qualification and Experience:

  • BS or MS in Protein Biochemistry/Biotechnology or related field with a 5+ years of industry experience in protein bio-therapeutics: scFv and MAb.

Job Responsibilities:

  • Experience with antibody/protein engineering techniques such as library screening (phage/yeast or in vitro display methods) and protein design is required.
  • Experience with standard molecular biology techniques such as cloning, PCR, Western Blots, DNA preps-maxi and mini, ELISA etc. Prior experience with rapid cloning methodologies using E-Gels and immuno-blotting using Iblot system are preferred.
  • Perform small-scale production, purification, and biochemical characterization of antibodies/ antibody fragments.
  • Perform molecular cloning and express antibodies, antibody fragments and antibody-like molecules in mammalian or bacteria cell cultures.Experience with antibody purification using protein A and size exclusion chromatography with automated equipment such as AKTA and Bio-Rad purification system is required.
  • Maintain multiple cell cultures and cell line types and perform cell transfections preferably HEK293 or CHO cells, protein expression and transfections and basic cell based bio- assays (binding, Bradford, MTT assay, signal transduction etc.).
  • Ability to focus on established and new-art science and technology to meet project needs for Discovery Sciences.
  • Support publication and patenting of scientific work.

  Other Requirements:

  • Ability to multi-task and manage multiple projects at the same time
  • Strong team player across various groups
  • Motivation to be part of a high performance, diverse, and efficient scientific team
  • Excellent spoken and written communication skills
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Candidate Qualifications:

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

Education/Certification

M.S. or Ph.D. in Chemical Engineering, Life Sciences or equivalent

Qualifications and Skills

  • Minimum of 6 years progressive industry experience with biologics drug product development and manufacturing of aseptic products
  • Operational experience with oversight of formulation, filtration, aseptic fill finish, shipping and distribution of drug product.
  • Experience in the specification, manufacture, development, and quality systems associated with auto-injector devices (21CFR820, etc…)
  • BLA/MAA authoring and marketed product support desired
  • Experience with packaging and labeling, global clinical supply management is a plus
  • Strong understanding of aseptic fill finish scale-up and validation is essential
  • 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
  • An assertive, take-charge, proven manager 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 mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization
  • Well-organized and accustomed to developing and managing budgets as well as maintaining excellent records

 

Opportunity and Summary of Position:

Associate Director, Drug Product & Supply Chain, is a new position, created to provide strong leadership as Oncobiologics continues its rapid growth. Associate Director, Drug Product & Supply Chain will be responsible for the development and tactical execution of drug product process development, manufacturing, validation through supply chain management for all biosimilar monoclonal antibodies and novel protein therapeutics.

Reporting Relationships:

Associate Director, Drug Product & Supply Chain will report to Senior Vice President, Development & Manufacturing.

 

Position Responsibilities:

  • Provide leadership to the organization for the development of sterile monoclonal antibody drug product manufacturing processes
  • Evaluate Contract Manufacturers and negotiate commercial pricing to enable company to meet cost of goods target
  • Oversee the execution of drug product manufacturing batches in vial and pre-filled syringe configurations for both clinical and commercial use
  • Perform “person in plant” duties as required during critical fills
  • Review tech transfer protocols, master batch records, and batch close-out documentation
  • Collaborates effectively with drug substance Process Development, Process Validation, Formulation Development, Analytical Sciences and internal Manufacturing.
  • Define and execute drug product validation master plan as well as supporting process characterization studies
  • Oversee leachables, sterility, shipping and other validations
  • Working with Quality Assurance, Regulatory and Clinical Operations, define and oversee Packaging and Labeling operation.
  • Oversee warehousing and distribution of global clinical supplies and plan commercial infrastructure
  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions and premarket approval applications
  • Lead the selection of appropriate auto-inject devices, their design development and manufacture
  • Represent the Company before EU and FDA regulatory authorities
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualification and Experience:

A MS/PhD degree with 2 - 4years with hands-on experience in microbial recombinant protein expression; including expression system construction and fermentation process development.   The applicant must have strong interpersonal skills and the desire to work in a high pace biotech environment.

Job Responsibilities:

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

Cell and Molecular Biology

  • Evaluate various Prokaryotic strains for optimal localization and expression of recombinant proteins.
  • Have a working knowledge and ability to construct microbial expression systems (promoters, secretion systems, induction systems, etc.)
  • Sequence verification
  • PCR, primer design, DNA extraction from bacteria
  • Restriction digests, ligations, transformations
  • Large-scale DNA preparation
     

Fermentation Process Development

  • In this role you will be responsible for the running of microbial fermentations (primarily E.coli) in shake flasks and 10-L fermenters for the expression of recombinant proteins (with CHO cell culture experience a plus).
  • Define and design experimental processes and protocols, operates (or directs others in operation) bioreactors/fermentors and/or recovery equipment.
  • Must possess working knowledge of standard production process methods i.e. batch and fed-batch fermentation methodology.
  • Develop research strategies, approaches and plans for fermentation projects and manage day to day fermentation research operation to meet project goals and timelines
  • Manufacture recombinant protein (0.5 – 2 g) to support early discovery POC models.
  • Compile and analyze experimental data in order to develop, optimize and monitor process performance.
  • Apply the latest knowledge of microbial physiology, secondary metabolism and biosynthetic pathways to media design, process optimization and strain improvement. 
  • Collaborate with scientists, engineers, and technicians in discovery and other departments.
  • Evaluate fermentation options, technical feasibilities, and costs for new projects.

Desired Key Competencies

  • Ability to understand and execute on the company’s mission and values.
  • Provides supports to the grouplead to meet project timelines in a fast-paced team environment.
  • Maintain a high degree of accuracy and attention to detail.
  • Well organized and capable of clear communication through technology.

Culture

  • 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 company.
  • Follow all company best practices to minimize cost and meet budgetary requirements while maintaining quality.
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualification and Experience:

  • PhD/MS in Chemistry/Biochemistry or related field. Minimum 2+ years of experience with PhD or 5+ years of experience with MS in the Analytical or QC laboratories in pharmaceutical or biopharmaceutical industry.
  • 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.
  • Should have familiarity with CMC and GMP requirements.
  • Demonstrated solid understanding of the principles and practices of 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 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 cross-functional teams.
  • Analyze in-process control samples, drug substances and drug products using technologies such as 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.
  • Lead junior scientists in Analytical Development to provide expertise in instrument maintenance and troubleshooting as well as resolution of OOS and OOT results.
  • Keep real-time experiment records and prepare SOPs, protocols, technical reports to support the process development and regulatory filling.
  • Assist Associate Director with purchasing of new equipment 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 cross-functional team work environment culture.
  • Support business development and strategies.
  • Follow best practices to reduce cost and meet budgetary requirements while maintaining quality.
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Oncobiologics is seeking a scientist with extensive industry experience to play an integral part and manage our Phage platform to screen hits and lead-optimization activities in the field of therapeutic scFv and antibodies. We are looking for an exceptionally talented scientist/leader with a track record of scFv/antibody discovery with a passion/drive for the growth and success of the company objectives in treating patient’s medical needs.

The Director will report to the Vice President of Discovery and Development Sciences.
 

Qualification and Experience:

  • PhD in a field of biological/ protein sciences, plus 15 years of program-leadership experience in biotechnology industry
  • Strong knowledge of scFv, antibody and biologic structure-activity relationships and protein engineering/computer modeling
  • Experienced in PHAGE screening, and bio assays, ELISA, Octet and flow cytometry/FACS
  • Knowledge of molecular biology, with recombinant DNA manipulation, PCR, cloning, subcloning
  • Strong molecular understanding in the therapeutic areas: oncology, immuno-oncology,  and inflammatory diseases
  • Experience in multiple external partnerships in discovery development with academic/medical labs
  • Broad knowledge of pre-clinical in-vitro assays and in-vivo animal test models
  • Experience managing a lab and proven ability to oversee multiple simultaneous projects timelines with lab personnel
  • Strong management skill in assisting the development of lab personnel  and to engaged their motivation/passion to succeed
  • protein sciences and biological-assay development and analytical skills in an industrial pharmaceutical or biotechnology environment
  • Extremely strong interpersonal skills, demonstrated ability to work in a highly collaborative environment and ability to achieve results though team work.
  • Extremely strong written and oral communication and presentation skills
     

Job Responsibilities:

  • Oversee and lead/manage a portfolio of discovery biologics programs and the Discovery team of 8 scientists including PhD’s.
  • Work with teams leaders to develop and maintain timelines and resource plans
  • Design, analyze and interpret experiments and development long term experimental plans  
  • Implement high-throughput methods for production, purification, and screening of lead hits isolated from specific selections criteria’s
  • Obtain input from all group leader and external collaborators/scientific advisory broad members on project goals and data.
  • Plan for the POC animal studies with lead-optimization activities
  • Critical-path management of scientific activities,  problem solving, and contingency planning
  • Required to work in the laboratory with the team
     

  Culture

  • Support business development activities as required.
  • Support solutions for innovation and all issues on collaboration.
  • Must be an excellent team member willing to work collaboratively
     
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualification & Experience:

BS or MS in Sciences or Engineering or equivalent experience will be considered. Ideal candidate would possess a comprehensive background in Sciences or Engineering with formal qualifications in regulatory affairs.

Minimum 5 years of experience in biopharmaceutical industry of at least 2 years in QA or regulatory affairs. Experience in R&D, manufacturing, or technical support is strongly desired as supplementary. Must have exceptional communication skills, both verbal and written, as well as excellent interpersonal skills. Experience with Quality Systems such as Document Control and Supplier Quality is preferred. Must be detail oriented, well organized and able to work independently and on teams.
 

Job Description:

This position will directly report to the Quality Assurance Director with the responsibilities including (but not limited to):

Quality Assurance (60%)

  • The Quality Assurance Specialist will be responsible for administration of quality systems required for biologics manufacturing of clinical supplies and licensed products.
  • Implement Oncobiologics Quality Plan and associated policies and procedures required for the Quality Assurance function.
  • Administrator for the Document Management System at Oncobiologics.
  • Ensure that the organization is compliant with relevant cGMPs, lead internal audit teams and ensure readiness for global health authorities inspections.
     

Quality Assurance - Other (20%)

  • Responsibilities include archivist for Oncobiologics.
  • Participate in subcontractor and supplier qualification, including vendor auditing (less than 10% travel expected).
     

Culture (20%)

  • Support business development activities as required.
  • Support solutions for innovation and collaboration.
  • Develop customer relationships with peers.
  • Department director may assign other responsibilities as required
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualifications & Experience:   BS in Engineering or equivalent life sciences degree

Minimum of 4 – 6+ years of experience.  Knowledge and/ or demonstrated ability in cGMP bioprocess operations of mammalian expressed glycoproteins or mAbs is preferred.  The applicant shall have excellent communication skills that facilitate operations in cross functioning groups.

 

Job 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.  This position will report directly to the Clinical Manufacturing Team Lead with responsibilities including (but not limited to):

Process Operations  (60%)

  • Performance of cGMP Operations in accordance with Standard Operating Procedures (SOP’s); Master Batch Records (MBR’s); Equipment Qualification Protocols; and other applicable instructional documentation.  Inclusive of:
    • Shipping, Receiving, Raw Material Release and Inventory Management
    • Weigh, Dispense and Solution Preparation
    • Upstream and Downstream Manufacturing Operations
  • 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.
  • Assist in lab experiments and document results in either paper or electronic lab notebook system.
  • Prepare analytical reagents, media and solutions required for process development.
  • Handle assembly and disassembly of laboratory equipment using glass washer, sonic sink, and autoclave.
  • Glassware wash and sterilization.
     

Equipment and Facilities (30%)

  • 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.

 

Culture (10%)

  • 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:

 

Qualifications & Experience:

BS/MS in Chemistry/Biochemistry or related field. Minimum of 7 years Quality Control laboratory experience in a pharmaceutical or biopharmaceutical industry.

Desirable to have experience with protein molecules, such as monoclonal antibodies. Demonstrated knowledge and experience with HPLC and UPLC techniques. Hands-on experience with ELISA assays for Host Cell Protein, residual DNA and Protein A desirable. Familiarity with cGMP requirements. Knowledgeable of USP, Ph. Eur. requirements for compendial testing. Demonstrated experience with performing method validation according to regulatory guidelines.

 

Responsibilities:

This position will directly report to Associate Director of Quality Control with the general responsibilities including but not limited to:

   Primary Duties (60%)

  • Perform routine testing to support manufacturing and stability. Analyze in-process control samples, drug substances, drug products using UV/Vis, CE-SDS, icIEF, SEC HPLC, SEC HPLC, CEX HPLC, Protein A HPLC, qPCR, ELISA and compendial assays.
  • Operate the instruments and interpret analytical data using Empower, Agilent, 32 Karat, SoftMax Pro, etc.
  • Perform method qualification and validation activities.
  • Write and revise test methods and SOPs.
  • Provide investigative analysis for nonconformance results.
  • Perform timely peer review of analytical results.
  • Assist in training junior analyst to perform assays.

   Secondary Duties (30%)

  • Provide compliance support for corrective actions preventive actions (CAPA) and Change Control.
  • Contribute to departmental activities such as safety inspections and internal audits.
  • Help troubleshoot and investigate analytical instrumentation and equipment issues.
  • Contribute to continuous improvement initiatives
  • Participate in maintaining inspection readiness.
  • Calibrates and maintains lab equipment.
  • Performs other duties as assigned.

   Culture (10%)

  • Foster a strong cross departmental team interactive culture.
  • Support business development and strategies activities as required.
  • Support solutions for new innovation and collaboration with peers in ONS departments.
  Location: Cranbury, NJ  (map)
View Description
Job Description:

 

This position will directly report to the Vice President, Regulatory and Clinical Affairs, and will be responsible for the supervision/preparation and critical review of high quality regulatory submissions to relevant health authorities. The Associate Director will evaluate complex regulatory issues and provide accurate and timely recommendations and alternatives, as needed. The Associate Director will establish regulatory strategies for submissions and manage document deliverables to assure submission targets are met while adhering to appropriate statutes, regulations and guidances. The Associate Director will represent Regulatory Affairs on project teams and serve as a regulatory team leader for projects.

Qualifications & Experience:

  • Minimum Bachelors degree in scientific discipline (Chemistry, Pharmacy, Biology, etc.).
  • 5-10 years relevant pharmaceutical experience
  • Understand the drug development process especially clinical development requirements.
  • Demonstrated track record of leading/managing positive health authority interactions and submissions.
  • Knowledge of global (US, EU, etc.) regulatory requirements for biologics and combination drug products a plus.
  • Knowledge and expertise in preparation of CTAs, INDs, and NDAs (BLAs).
  • Ability to support and effectively multi-task different and complex assignments and responsibilities.
  • Understand, identify, mitigate, and communicate risks at the study or program level.
  • Strong oral and written communication skills.
  • Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint.

Job Responsibilities:

  Primary Duties (60%)

  • Manage the preparation, compilation, and submission of high quality original submissions (ex. CTAs,  INDs, BLAs, MAAs), required forms (1571, 1572, 356h, etc), amendments, supplements, annual reports, control documents, etc. to health authorities.
  • Formulate regulatory strategy and tactics for all assigned regulatory submissions. Evaluate changes to regulatory documents and formulate a strategy to ensure proper filing categories. Work intimately with functional areas/CROs throughout the drug development process to ensure compliance with all regulatory requirements.
  • Ensure that the regulatory requirements are met for associated documents such as clinical protocols, Investigator Brochure, labeling, etc.
  • Maintain full awareness of all regulatory activities on assigned projects to assure that the project deadlines and performance standards for these projects are established and met.
  • Interface with the FDA and other health authorities, as appropriate to facilitate acceptance/approval of regulatory submissions.  Coordinate with appropriate personnel and departments to resolve any regulatory questions or filing issues.
  • Act as primary contact/liaison representing Regulatory Affairs with health authorities, internal functional areas, contract customers, and partners as assigned.

   Secondary Duties (30%)

  • Keep current with the FDA/ICH and other pertinent health authority regulations pertaining to biosimilar, innovator and regulatory filing requirements by independent learning, attending conferences and symposia.
  • Collaborate with Clinical Affairs, Quality Assurance, and other operation functions to develop strong regulatory strategies and assure regulatory compliance with documentation.

   Culture (10%)

  • 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 Manager or Director, Business Development, is a new position, created to provide execution support as Oncobiologics continues its rapid growth.  This position will be responsible for execution and support of global business development strategies for biosimilar monoclonal antibodies and novel protein therapeutics, and the platform technologies that support the R&D of such large molecules.  This position will report to the Senior Vice President, Business Strategy & Development.

Qualification and Experience:

  • Ph.D. in Molecular/Cellular Biology, Biochemistry, Protein Engineering or related field and/or post-degree research experience, or MS with broad technical background and an emphasis on current/emerging biomedical research technologies
  • Effective oral and written communication skills
  • Preferred candidates will have at least 6 years full-time licensing and/or business development experience negotiating agreements for biomedical technologies and/or compounds at various stages of development (biologics experience preferred)
  • Strong interpersonal skills and extensive knowledge of patent and contract law is advisable.
  • Functions effectively in a team-minded environment

Other Requirements:

  • Minimum of 6 years of progressive biopharmaceutical experience with some interactions with biologics research and development
  • Strong understanding of protein characterization would be a plus
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and manufacturing 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
  • An assertive, take-charge, proven manager with strong results track record, a positive “can do” attitude who enjoys challenges, and a sense of urgency toward accomplishment; however, the successful candidate should also possess the ability to listen to, learn about, and build upon organizational best practices and successes.
  • A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities
  • Well-organized and accustomed to aligning with established budgets as well as maintaining excellent records

Job Responsibilities:

  • Monitoring and evaluating key developments and trends in biomedical research, including biosimilar development guidelines, clinical trial accrual trends, new technologies for accelerating Drug Discovery, etc.
  • Work with internal scientific management to establish strategic technology needs and priorities, and establish appropriate outsource partnerships
  • Support a program to source and evaluate technologies and/or collaborations that complement or supplement ongoing research activities
  • Negotiate and structure agreements to acquire requisite technologies, or establish agreements defining CRO/CMO partnerships
  • Secure management approval and execution of agreements and manage post-execution issues – negotiate amendments and/or terminations as required.
  • Represent Oncobiologics to external biotechnology, large pharma and/or academic institutions
  • Network to establish and maintain contacts with leading industry and large pharmaceutical investigators and licensing/business development functions
  • Manage existing and/or future large pharma alliances as the “Alliance Management” function and infrastructure is developed
  • Support possible IPO road show and diligence as required

 

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 and Experience:

PhD/MS/BS in Biochemistry, Chemistry, Chemical Engineering or equivalent.  Minimum 12+ years of experience in absence of graduate degree, 8+ years if MS, or 6+ years with PhD; must have demonstrated ability to design and evaluate experiments; at least basic skills in use of statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with creating solutions in a transparent and matrix team environment; must have experience with purification of proteins expressed in both mammalian and bacterial systems (monoclonal antibodies/small binding proteins and single chains) including conventional chromatographic techniques, solubilization and refolding of insoluble proteins and various filtration techniques (TFF, depth and nanofiltration). Should have experience in design and execution of viral clearance studies for both early and late stage development projects. Should have experience with performing technical transfer of developed processes to internal/outsourced groups including appropriate documentation. Should have familiarity with the GMP’s. Must have strong focus on collaborations with an eye toward creativity and continuous improvement. Strong knowledge of analytical chromatography required.
 

Job Responsibilities:

This position will report to the Head of Purification Development with responsibilities including (but not limited to):

   Purification Development (50%)

  • Conceptual design, development and implementation of purification processes for proteins expressed in both mammalian and microbial host systems.
  • Evaluation of chromatography resins and membrane adsorbers (e.g. including 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 laboratory notebook with scientific rigor to meet project needs for process development.
  • Prepare and review documents associated with technical transfers of developed processes to manufacturing partners (either internal or outsourced)
  • 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 methods, ELISA and associated equipment.
  • Represent purification development in team meetings as required.
     

Equipment and Facilities (30%)

  • 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.
  • Interested in automated high-throughput process development capabilities implementation.
  • 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.
     

  Culture (20%)

  • Must be proficient in Microsoft Office Suite (Word, Excel, Powerpoint).
  • Document writing and review skills required.
  • Support business development activities as required.
     
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

Overview:

This position will directly report to the Vice President, Regulatory and Clinical Affairs, and is focused on CMC Regulatory strategy and execution.  This position will also be responsible for understanding technical issues/information to implement the appropriate CMC regulatory strategy.  In addition, responsibilities include authoring CMC sections, as well as plan, prepare and critically review high quality regulatory submissions to relevant health authorities focused on the CMC aspects of development. The Associate Director evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed to assist the efficient development of biosimilar molecules. The Associate Director will establish regulatory strategies for CMC submissions and manage document deliverables to assure submission targets are met while adhering to appropriate statutes, regulations and guidances.  

Qualifications:

  • Minimum Bachelor degree in scientific discipline (Chemistry, Pharmacy, Biology, etc.).
  • 5-10 years relevant pharmaceutical experience

Experience Preferred:

  • Understand the drug development process especially CMC development requirements.
  • Demonstrated track record of leading/managing positive health authority interactions and submissions.
  • Knowledge of global (US, EU, etc.) CMC regulatory requirements for biologics and combination drug products a plus.
  • Knowledge and expertise in preparation of CTAs, INDs, and NDAs (BLAs).
  • Ability to support and effectively multi-task different and complex assignments and responsibilities.
  • Understand, identify, mitigate, and communicate risks at the study or program level.
  • Strong oral and written communication skills.
  • Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint.

 

Job Responsibilities:

  A.  Primary Duties (60%)

  • Manage and/or author the preparation, compilation, and submission of CMC sections of original submissions (ex. CTAs, INDs, BLAs, MAAs), required forms (1571, 356h, etc), amendments, supplements, annual reports, control documents, etc. to health authorities.
  • Work intimately with functional areas/CROs throughout the drug development process to ensure compliance with all CMC regulatory requirements.
  • Formulate CMC regulatory strategy and tactics for all assigned projects and regulatory submissions. Evaluate changes to regulatory documents and formulate a strategy to ensure proper filing categories.
  • Ensure that the CMC regulatory requirements are met for associated documents such as clinical protocols, Investigator Brochure, labeling, etc.
  • Maintain full awareness of all CMC regulatory activities on assigned projects to assure that the project deadlines and performance standards for these projects are established and met.
  • Interface with the FDA and other health authorities, as appropriate to facilitate acceptance/approval of the CMC content of regulatory submissions.  Coordinate with appropriate personnel and departments to resolve any regulatory questions or filing issues.
  • Act as primary contact/liaison representing Regulatory Affairs with health authorities, internal functional areas, contract customers, and partners as assigned.

  B.    Secondary Duties (30%)

  • Keep current with the FDA/ICH and other pertinent health authority regulations pertaining to CMC guidance for biosimilar, innovator and regulatory filing requirements by independent learning, attending conferences and symposia.
  • Collaborate with technical SMEs, Quality Assurance, and other operation functions to develop strong CMC regulatory strategies and assure regulatory compliance with documentation.

 C. Culture (10%)

  • 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: Offisite: Cranbury, New Jersey  (map)
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Job Description:

 

Qualifications & Experience:

  • Minimum Bachelors degree in scientific discipline (Biology, Nursing, Pharmacy, etc.).
  • 5-10 years relevant pharmaceutical experience.
  • Understand the drug development process especially clinical development requirements.
  • Demonstrated track record of leading/managing clinical trials.
  • Explicit knowledge of global (ICH, US, EU) regulatory requirements for clinical study conduct.
  • Ability to support and effectively multi-task different and complex assignments and responsibilities.
  • Understand, identify, mitigate, and communicate risks at the study or program level.
  • Strong oral and written communication skills.
  • Proficiency in computer applications such as Microsoft Project, Word, Excel, and PowerPoint.

Responsibilities:

   Primary Duties

  • Develop and manage study timelines (including recruitment) and may develop and manage program timelines
  • Convene and lead cross-functional clinical trial teams (CROs) including Operations Oversight
  • Define and manage accountabilities for all clinical trial team members
  • Collaborate with Project Management to ensure proper resourcing and timelines for assigned trials
  • Manage information and submit to clinicaltrials.gov database
  • Contribute to the Clinical Study Protocol and may contribute to the Protocol Concept Sheet
  • Develop outsourcing specifications for vendor requests for proposal and scope of work agreements
  • May participate in vendor selection (clinical CRO, data management, etc)
  • Collaborate with Clinical Affairs, Project Management, Quality Assurance, and other operation functions to develop strong clinical plans and assure regulatory compliance with documentation.

   Culture

  • 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)
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Job Description:

 

High School Diploma or Associates Degree from an accredited institution.  Minimum of 0-4 years of experience.  The applicant shall have excellent communication skills that facilitate operations in cross functioning groups.  The applicant shall have the ability to drive a 26’ Long Truck. 

Physical Requirements

  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
  • Must have the ability to stand for long periods of time.
  • 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).

This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedules.  Weekend, holiday and shift work may be required based on manufacturing schedule as determined by Area Management.

 

JOB RESPONSIBILITIES

   Process Operations (80%)

  • Performance of cGMP Operations in accordance with Standard Operating Procedures (SOP’s); Master Batch Records (MBR’s); Equipment Qualification Protocols; and other applicable instructional documentation. 
  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards.
  • 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.

   Equipment & Facilities (10%)

  • Participate in starting up facility and process equipment.
  • Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency

   Culture (10%)

  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.
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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:

 

Qualifications & Experience:

  • MS/ BS in Biochemistry/Biotechnology or related field
  • MS with 0-2 years and BS with 2 years of experience in performing functional testing of protein biotherapeutics (mAbs, antibody fusion proteins, and other protein constructs) 
  • Hands on experience with aseptic techniques and cell culture techniques required
  • Experience with cGMP regulations preferred 
  • Motivation to be part of a high performance, efficient scientific team
  • Excellent spoken and written communication skills

 

Job Responsibilities:

   Assist BioAssay Group in the Development of Cell Based and Binding Assays  (80%):

  • Develop functional assays including cell based assays, ELISAs and binding assays under the supervision of senior scientists
  • Independently maintain cell cultures, prepare reagents, and perform various bioassays
  • Prepare lab document/protocols
  • Maintain the bioassay lab and equipment
  • Stay abreast with new advances in science and technology to meet project needs for Bioassay group
  • Work closely with other departments to support QC, Process development and Formulation development activities
  • Provide support through Bioassay testing for regulatory filings and publication and patenting of scientific work

   Culture (20%):

  • Support business development activities as required.
  • Support solutions for innovation and collaboration.
  • Develop customer relationships with peers.
  Location: Cranbury, NJ  (map)
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Job Description:

 

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

   Education/Certification

  • B.S. or M.S. in Chemical Engineering, Life Sciences or equivalent

   Qualifications and Skills

  • Minimum of 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
  • The applicant should have an in-depth knowledge in the principles of process scaling from process development to clinical manufacturing as well as 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 biosimilars or comparability is a plus
  • 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
  • An assertive, take-charge, proven manager 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 mature thinking and acting manager with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization
     

Job Description:
Senior Manager/ Group Leader, Manufacturing Support, will be responsible for the introduction of all biosimilar candidates from process development to the Biologics Manufacturing Center. Position will report to Director, Clinical Manufacturing.

Position Responsibilities:

  • Lead a multi-disciplined group (currently 4 FTEs) responsible for process engineering, equipment qualification, and logistics
  • Creation of RFP’s and URS’ for customized automation and integration of packaged systems such as single use bioreactors, chromatography systems, TFF systems, depth filtration systems
  • Lead evaluation of electronic systems to replace paper based systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance
  • Execution of site VMP to ensure a constant state of compliance in a multi-product/ multi-phase manufacturing facility
  • Review, oversight and coordination of equipment qualification program
  • Author, review, and/or approve documentation, 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 process non-conformances and deviations
  • Ensure seamless and rapid technology transfers from Process Development through the review technology transfer protocols and participation on project development teams
  • 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 process data from clinical batches to establish critical processing parameters and PAR
     
  Location: Cranbury, NJ  (map)
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Job Description:

Qualification & Experience:

A BS/MS degree with a minimum of 10 years or a PHD degree with 5 years hands-on experience in antibody/protein analyses with various liquid chromatography, liquid chromatography-mass spectrometry methods and biophysical characterization. The Senior Scientist must have strong interpersonal skills and the desire to work in a high pace biotech environment.

 

Job Responsibilities:

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

Analytical Support for Process Development, GMP Manufacture, Formulation and Drug Discovery

  • Effectively interact with Cell Line Development, Upstream, Downstream, Formulation and Drug Discovery to support biologics development.Ensure timely support.
  • Take a lead for conducting routine testing in support of antibody/protein glycosylation characterization (N-glycans, monosaccharaides, sialic acid), primary structure characterization (amino acid sequence coverage analysis, molecular weight determination, amino acid composition analysis, cysteine conformation, free thiol content) and post translational modifications characterization.
  • Responsible for method development of carbohydrates analysis, glycation, acidic/basic species of charge isoforms identification and mass spec new methods.
  • Responsible for assay qualification, validation and assay transfer/training.
  • Take a lead for troubleshooting of analytical issuers.
  • Provide training to juror scientists.
  • Maintain accurate and timely data records and documentation. Writes SOPs and updates and keeps them current.
  • Work with CRO for biophysical characterization.
  • Write publication of scientific work.

Desired Key Competencies

  • Ability to understand and execute on the company’s mission and values.
  • Provides supports to the grouplead to meet project timelines in a fast-paced team environment
  • Maintain a high degree of accuracy and attention to detail.
  • Well organized and capable of clear communication through technology.

Culture

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

Qualifications:

  • Ph.D. /MS or BS in biology, cell biology, biochemistry or related field.
  • Ph.D. with up to 2 years, M.S. a minimum of 6 years, and B.S. with a minimum of 9 years of experience in developing cell based bioassays, immunoassays and/ or ligand binding assays for release, stability and characterization.
  • Proven track record of providing scientifically sound results while multitasking in a fast paced environment.
  • Effective communicator in a team oriented group based environment.
  • Experience in both research based and GxP environments.

Experience:  

Development, testing, and maintenance of assays that evaluate cell based functional potency in release, stability, and process development test articles. Experience in assay development aimed at determining test article structure/function attributes. Experience in development and routine performance of SPR/ BLI based ligand binding assays (Biacore, Octet) is highly desired.

Job Responsibilities:

Assist the Analytical Development Group in the development and performance of bioassays (70%)

  • 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 thorough understanding of regulatory guidelines of assay design, development and analysis
  • Provide support through bioassay testing for release, stability, process development and formulation development activities
  • Provide support thorough bioassay development and testing for investigational studies aimed at establishing structure-function correlation
  • Possess the requisite technical skills such as aseptically maintain multiple cell lines, design, perform and analyze multi-well assays
  • Focus on established and state-of-art science and technology to meet project needs for analytical sciences
  • Ability to collaborate, work closely and support future QC and Process Development activities on scientific issues
  • Ability to troubleshoot and maintain the equipment utilized within the department.
  • Maintain equipment logbooks and electronic notebook entries

Support publication and patenting of scientific work (20%)

Collaborate with various vendors and discovery centers to develop innovative novel assay platforms. Participate in collaborative cross-departmental projects to investigate biologics degradation pathways, structure-function relationships and mechanisms and pathways of action drug

Culture (10%)

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

 

 

 

  Location: Cranbury, NJ  (map)