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: 14 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:

  • Ph.D. degree with 1-3 years of experience or MS degree with 5-7 years of experience in relevant fields of biopharmaceutical industry.
  • Demonstrated solid understanding of the principles and practices of analytical separation methodologies and technologies with direct hand-on experiences.
  • Proven record of working independently to develop and qualify analytical methods using cutting-edge technologies.
  • Proven track record of maintaining quality and productivity to support process development.
  • Proven ability to multi-task in a fast moving corporate environment.
  • Demonstrated sound ability to communicate scientific problems in a cross functional environment.
  • Working experience in cGMP and QC environment a plus.

Job Description:

  • Work closely within Analytical Science to support Process Development, including cell line development, upstream and downstream process and formulation development.
  • Perform method development and testing, such as A280, CE-SDS, icIEF, SEC, CEX, Affinity Protein A, qPCR, ELISA, etc.
  • Analyze and interpret analytical data using Empower, Chemstation, Astra, 32 Karat, 7500 SDS, etc., and present meaningful results to cross-functional teams.
  • Formulate an idea and solution to resolve the gap and perform trouble shooting of a method. Follow through the development cycle of a method.
  • Perform basic statistical analysis and design of experiment (DoE) to support method development and optimization.
  • Lead the activities of method optimization, qualification and validation; prepare protocols and reports to support CMC and regulatory filing.
  • Keep accurate and timely experiment records and documentation.
  • Maintains tidiness, safety and organization in laboratory areas.
  • Lead junior scientists to conduct investigation.
  • Able to work additional hours as needed.

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 Biochemistry/Biotechnology or related field.

Minimum of 5 years relevant experience in analytical sciences of protein biotherapeutics (mAbs, antibody fusion proteins, and other protein constructs).

Hands on experience with HPLC equipment (instrument and detectors), Microplate shakers/washers/readers, and/or Capillary Electrophoresis instrumentation is required. Experience with cGMP regulations preferred. Motivation to be part of a high performance, diverse, and efficient scientific team. Excellent spoken and written communication skills.

 

Job Responsibilities:

Assist the Analytical Development Group in the development and performance of characterization and process impurity assays (70%)

 

  • Provide support, through analytical testing, of process development activities
  • Possess the capability to develop analytical testing assays for the characterization of Oncobiologics constructs
  • Possess the capability to develop analytical testing assays for the quantitation/qualification of process manufacturing impurities.
  • Ability to troubleshoot and maintain the equipment utilized within the department.
  • Maintain equipment logbooks and electronic notebook entries
  • Focus on established and new-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.
     

Support publication and patenting of scientific work (20%)

Collaborate with various vendors and discovery centres to develop innovative novel analytical methodologies. Develop methods for qualification of analytical methodologies. Setup multi-platforms to be used to access biologics degradation pathways, and comparability protocols

 

Culture (10%)

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

  Location: Cranbury, New Jersey  (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 degree with 1-3 years of experience or BS degree with 3-5 years of experience in relevant fields of biopharmaceutical industry.
  • Understanding of the principles and practices of analytical separation methodologies and technologies with direct hand-on experiences.
  • Hands-on experience with analytical testing, analysis and report.
  • Working in an analytical development team to support process development.
  • Ability to multi-task in a fast moving corporate environment.
  • Ability to communicate scientific problems in a multi-functional environment.
  • Working experience in cGMP and QC environment a plus.

Job Description:

  • Work closely within Analytical Science to support Process Development, including cell line development, upstream and downstream process and formulation development.
  • Perform analytical testing, such as A280, CE-SDS, icIEF, SEC, CEX, Affinity Protein A, qPCR, ELISA, etc.
  • Analyze and interpret analytical data using Empower, Chemstation, Astra, 32 Karat, 7500 SDS, etc., and present meaningful results.
  • Understand basic statistical analysis and tools based on design of experiment (DoE) to support method development and optimization.
  • Perform method optimization, qualification and validation; prepare protocols and reports.
  • Keep accurate and timely experiment records and documentation.
  • Maintains tidiness, safety and organization in laboratory areas.
  • Able to work additional hours as needed.

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:

 

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.
View Description
Job Description:

 

Qualifications & Experience:

BS/MS/PhD in Biochemistry/Biotechnology/Analytical Chemistry or related subject area.

Minimum 5 - 6 years of relevant industry experience with focus on analytical quality control and analysis testing support for raw material release, drug substance/drug product lot release and stability for Biological Manufacture Center, Oncobiologics. The QC Senior Scientist will be responsible for QC lab operation management,QC method/data management and provides supports to QC head to meet project timelines in a fast-paced team environment

 

 

Job Description

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

Analytical Support for Biological Manufacture Center

 

  • Effectively interact with BMC and CRO for raw material release. Review and approve analytical test method/specification/results of raw material tested either in-house or by CRO in accordance with cGMP regulations. Ensure CROs are following analytical procedures and specifications.
  • Oversee sample submission tracking and document tracking used to the Quality Control laboratory specifying tests required for lot release, stability and cleaning validation.
  • Review of test results of drug substance, finished products, stability and microbiology samples using in-house and EP/USP methods for lot release and stability evaluation.
  • Update and track stability testing database as samples are tested and reviewed.
  • Coordinate the change control and planned deviations requests applicable to stability, lot release and raw material sample.
  • Review SOP’s, analytical procedures and product specifications to ensure that all standards are met in accordance with cGMP and company guidelines/FDA and EMA regulations.
  • Communicate review findings to QA/QP, discuss various approaches recommend solutions to audit findings and suggest appropriate CAPAs
  • Maintain and control laboratory documentation within QC.
  • Provide training to juror scientist. Responsible for QC lab safety.

Desired Key Competencies

  • Ability to understand and execute on the company’s mission and values.
  • Maintain a high degree of accuracy and attention to detail.
  • Well organized and capable of clear communication.

Culture

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

Qualifications:

  • Ph.D./MS or BS in biology, cell biology, biochemistry or related field.
  • With a M.S. a minimum of 6 years of experience in cell culture and developing cell based bioassays and/or immunoassays for the purpose of monitoring selective product quality attributes required. With a B.S. a minimum of 9 years of relevant experience in cell culture and developing cell based bioassays and/or immunoassays for the purpose of monitoring selective product quality attributes required.
  • 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. A thorough understanding of cell culture techniques is required. Experience in assay development aimed at determining test article structure/function attributes. Experience in assay development and testing of SPR based assays (Biacore, Octet) is desired.

Job Responsibilities:

Assist the Analytical Development Group in the development and performance of characterization and process impurity assays (70%)

  • Provide support, through analytical testing, of process development activities
  • Possess the capability to develop analytical testing assays for the characterization of test article product quality attributes
  • Possess the capability to adequately maintain, through properly established cell culture techniques,  project related cell lines.
  • Ability to troubleshoot and maintain the equipment utilized within the department.
  • Maintain equipment logbooks and electronic notebook entries
  • Focus on established and new-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.

Support publication and patenting of scientific work (20%)

Collaborate with various vendors and discovery centres to develop innovative novel analytical methodologies. Develop methods for qualification of analytical methodologies. Setup multi-platforms to be used to access biologics degradation pathways, and comparability protocols.

Culture (10%)

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

 

 

 

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

 

Qualification & Experience:

High school with technical school, apprenticeship program or equivalent experience.  Minimum of 10 years of experience with demonstrated knowledge and abilities in facility and equipment operation and maintenance.  The applicant should have the skills to troubleshoot and repair malfunctioning manufacturing and facilities equipment.  The applicant should have abilities in general facilities work including plumbing, carpentry, HVAC, and electrical work. Prior pharmaceutical experience preferred.

Job Description:

This position will work diligently to meet scheduled timelines, and will work overtime as required to support operations.  Weekend, holiday, off shift, and call in work may be required to maintain operations.  This position will report to the Manager of Facilities and Environment Health and Safety with responsibilities including (but not limited to):

Research & Development and cGMP Equipment Maintenance (40%)

  • Perform equipment inspections and preventative maintenance on cGMP facility, lab, and manufacturing equipment.
  • Coordinate and supervise contractors as needed for repairs, calibrations, preventative maintenance, and construction work.
  • Make necessary repairs to equipment as needed.
  • Maintain equipment calibration and maintenance history and records.

Research & Development and cGMP Facility Infrastructure (40%)

  • Maintain and repair facility systems and utilities including, but not limited to:  HVAC, electrical, plumbing, DI water system, steam system, Bio-hazardous waste removal, specialty gases, compressed air system, housekeeping, security system, environmental health and safety.
  • Make necessary repairs to the facilities as needed.
  • Coordinate and supervise sub-contractors for modifications, maintenance and repairs of the existing facilities.
  • Purchase parts and materials as needed, maintain supplies for facility and equipment.
  • Maintain security and fire systems.
  • Maintain facility maintenance history.
  • Operate and maintain forklift.

Culture (20%)

  • Work with Facility manager and all departments to deliver efficient low cost solutions for maintenance of facilities and equipment.
  • Follow full cGMP guidance and fulfill all regulatory requirements at all times.
  • Maintain all equipment and facilities in a safe and environmentally conscious manner.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management may assign other responsibilities as required.
  Location: Cranbury, New Jersey  (map)