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:

 

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

The Scientist will be reporting to the Project Leaders of Discovery Sciences.

 

Qualification and Experience:

  • PhD/MS in Biotechnology/Chemical Engineering/Biological Sciences, plus 2-5 years of experience in biotechnology industry
  • Strong knowledge of scFv, antibody and biologic structure-activity relationships, stability and protein engineering/computer modeling
  • Experienced required in: phage panning including solution and cell based screening, Bioassays, ELISA, Octet/Biacore and Flow Cytometry /FACS
  • Working hands on experience in cell culture and cell based assays
  • Knowledge of molecular biology, with recombinant DNA manipulation, PCR, cloning, subcloning using novel technologies such as E-Gels and Clonewell Technology
  • 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 multiple simultaneous projects timelines with team members
  • 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:

  • 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
  • Present and report research progress in individual meetings and group meetings in a professional manner, prepare project reports and project experimental timelines.
  • Scientific activities involving: implementation/application of theoretical concepts, problem solving, and contingency planning
  • Experience with automated equipment and flexibility to learn and set up new equipment and novel technologies
  • Plan for the proof of concept cell based assays and animal studies with lead-optimization activities

  Other Requirements:

  • 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 and Experience:

MS/ PhD in Cell Biology/Biotechnology or related subject area.

Minimum 8 years of experience with a proven track record in Bio-Assay sciences of biologics encompassing issues related to QC, regulatory, comparability, process development, manufacturing. Individual must be flexible, with strong leadership and people skills to direct a highly trained scientific team. Hands on experience is also essential.
 

Job Responsibilities:

  Lead Bio-Assay group in development of biologics (60%)

  • Oversee and direct all aspects of bio-assay Development
  • Establish immunoassays, receptor assays, ligand-binding assays, cell-based assays, potency assays, and monitor biologics activity
  • Develop bio-assay methodologies required by Process Development for analysis of in process testing, drug substance and drug product.
  • Design and execute a comprehensive program on protocols for regulatory compliance (FDA/EMA/ROW).
  • Champion and guide the group to focus on established and new art science bio-assay and technology/ methodologies to meet project needs of Development Sciences.
  • Publish and patent scientific work and present work in leading international conferences.

  Assist and Development of Technologies (30%)

  • Maintain multiple cell cultures and cell line types
  • Perform various biological assays (cell based, ELISA’s, binding assays, molecular assays, etc). Knowledge of cell based assay development is required with experience in developing cell based bioassays
  • Experience with Forte Bio Octet/Biacore and FACS will be required
  • Evaluate CRO/CMO labs for Bio-assay testing capabilities.
  • Assist in the development of all quality systems required for biologics manufacturing for release and stability testing of clinical supplies related to CMC issues.
  • Assist in planning and compilation of critical documentation relating to the Bio-assay issues on global regulatory requirements for the development of biologics encompasses CMC, non-clinical and clinical development.

  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 Oncobiologics departments.
  • 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. in Protein Biochemistry/Biotechnology or related subject area. Minimum of 15 years of experience with a proven track record in formulation sciences of biologics encompassing issues related to QC, regulatory, comparability, process development, manufacturing and global commercialization.  Individual be must flexible having strong leadership and people skills in directing a highly trained scientific team to meet all company objectives.

Job Responsibilities:

This position will directly report to the VP of Discovery & Development Sciences with responsibilities including but not limited to:

Lead Formulation group in development of biologics (60%):

  • Foster a strong cross departmental team interactive culture.
  • Champion and guide the group to focus on established and new art science and technology/ methodologies to meet project needs of Development Sciences.
  • Develop formulation methodologies required by Process Development for analysis of in process testing, drug substance and drug product.
  • Design and execute a comprehensive program on formulation development and stability study protocols for regulatory compliance FDA/EMA/ROW.
  • Work closely and support all analytical scientific issues related to both internal and external GMP and Process Development.
  • Publish and patent scientific work and present work in leading international conferences.
  • Direct the development of Biophysical Methods and troubleshoot issues in formulation development.
  • Define stability program and support QC labs in execution and data analysis
  • Apply methodologies for rapid development of protein formulations of both novel and biosimilar molecules
  • Lead or support as required the phase appropriate Qualification/validation of methods in conjunction with internal and external QC groups
  • Collaborate with process development to provide rapid turnaround of sample queue according to project priorities
  • Capability for laboratory bench work
     

Assist in the functional issues of GMP and Process Development Technologies (30%)

  • Evaluate CRO/CMO labs for formulation testing capabilities.
  • Implement the qualification of methods and oversee their transfer to CMO.
  • Assist in the development of all quality systems required for biologics manufacturing for release and stability testing of clinical supplies related to CMC issues.
  • Review procedural documents related to analytical/formulation testing
  • of both internal and external manufactured lots of drug substance and drug product.
  • Assist in planning and compilation of critical documentation relating to the stability and formulation issues on global regulatory requirements for the development of biologics encompass CMC, non-clinical and clinical development.
  • Participate as a key member of the biosimilar development team
  • Support assays required for non-clinical and clinical as required
  • Oversee reference product suitability for setting specifications
  • Author appropriate global CMC regulatory sections for pre-submission meetings, IND/IMPDs, and routine questions and responses on stability /formulation
  • Support business development in presenting formulation topics in potential partnering discussion and by providing timely reports, and responses to questions when required

Culture (10%):

  • Support business development and strategies activities as required.
  • Support solutions for new innovation and collaboration with peers in ONS departments.
  • 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 & Experience:

BS in Engineering Discipline, preferably Chemical Engineering.

4-8 years of experience with demonstrated ability in clinical cGMP bioprocess operations and scale-up, particularly downstream processes, of mammalian expressed glycoproteins or mAbs.  The applicant should have a working knowledge in the principles of process scaling from process development to clinical manufacturing as well as single-use technology. 

The applicant shall have excellent communication skills that facilitate operations in cross functioning groups.  Experience/ knowledge of biosimiliar process development/ manufacturing is a plus.

 

JOB RESPONSIBILITIES

This position will report to the Director of Clinical Manufacturing with responsibilities including (but not limited to):

Process Operations (50%)

  • Play a lead role in the technology transfer of upstream and downstream processes from process development labs to internal clinical manufacturing and external commercial manufacturing facilities.
  • Creation and revision of documentation, including but not limited to equipment specifications, qualification protocols, technology transfer documentation, master batch records, standard operating procedures, production bill of materials, and process flow diagrams under QbD philosophies
  • As production schedule requires, performs upstream and downstream process operations as needed.
  • Champions risk-based documented approaches in collaboration with Process Development, Manufacturing and Quality Assurance
  • Ensures critical processing parameters have been defined in cGMP documentation
  • Develops training requirements for staff and assures that training is effective
  • Works diligently to meet scheduled timelines, especially as required to meet production schedule.

 

Equipment and Facilities (30%)

  • Participate in starting up facility and process equipment.  Partner with vendors to deliver state of the art technologies
  • Innovate technologies that embrace QbD, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency
  • Follow full cGMP guidance and fulfill all regulatory requirements at all times.
  • Operate safely and according to company environmental requirements.
     


   Culture (20%)

  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Present data or ideas in team meetings.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.
  • Status:  Exempt.
     
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

 

Qualification & Experience:

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

Minimum 10 years of experience in biopharmaceutical industry of at least 5 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 Health inspections by global authorities 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 Manager will act as back up to the department director.
  • Play support role in the development of all quality systems required for biologics manufacturing and release and stability testing of clinical supplies.
  • Responsible for recruitment of highly talented staff.
  • Implement Oncobiologics Quality Plan and associated policies and procedures required for the Quality Assurance function.
  • Review and approve all procedural documents from manufacturing and analytical testing.
  • Disposition of both internal and external manufactured lots of cell banks, drug substance and drug product including raw material release, batch record review and approval, certificate of analysis approval and investigation of non-conformance events.
  • Provide quality review of facility design and enable validation of both production equipment (mainly single-use technology) and analytical instrumentation.
  • Ensure that the organization is compliant with relevant cGMPs, lead internal audit teams and ensure readiness for global health authorities inspections.

Quality Assurance - Other (20%)

  • Develop Quality Risk Management plan and implement risk management techniques along with development and manufacturing.
  • Review stability program for expiration dating.
  • Certain responsibilities of the QA Manager will be delegated to other QA staff as the department grows.

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:

 

Director, Regulatory Affairs, is a new position, created to provide strong leadership as Oncobiologics continues its rapid growth. This key position will be responsible for the development and tactical execution of global regulatory strategies for biosimilar monoclonal antibodies and novel protein therapeutics.

In the next 12 months, the successful candidate will have filed IND’s (or EU equivalent) on at least two (2) biosimilar molecules, and been instrumental in corresponding Phase 1/Phase 3 clinical trials.

This position will report to the Chief Executive Officer.
 

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

   Education

  • M.S. or Ph.D. in Pharmaceutics, Life Sciences, Protein Engineering or equivalent
  • RAC or QA Certification is a benefit and is highly preferred.

   Qualifications & Skills

  • Minimum of 10 years progressive industry experience with biologics development and at least 8 years in Regulatory Affairs
  • Successful track record with BLA/MAA required – direct responsibility for at least one BLA/MAA is preferred
  • Strong understanding of protein characterization is required
  • Practical ‘hands-on” experience in handling US and/or EU registration procedures and other key countries/regions; i.e., prior experience with IND, IMPD and CTD is desired.
  • Development experience with biosimilars is ideal and/or prior experience with comparability as it applies to monoclonal antibodies
  • Specific regulatory experience with either immunology or oncology indications
  • 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
  • Ability to balance regulatory compliance requirements and business goals ensuring a positive result for both patient and company.
  • 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
  • Ability to balance regulatory compliance requirements and business goals ensuring a positive result for both patient and company.
  • Well-organized and accustomed to developing and managing budgets as well as maintaining excellent records
     

Job Responsibilities:

  • Provide leadership to the organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
  • Develop creative and flexible regulatory approaches for biosimilar monoclonal antibody development, with consideration of evolving global regulations and phase-appropriate applications
  • Assist in assessing comparability as it relates to biosimilar development, and support the justification of associated specifications
  • Interpret global regulatory requirements for the development and commercialization of monoclonal antibodies and derivatives thereof, i.e., scFv, bispecifics, ADC’s. Such requirements will encompass CMC, nonclinical and clinical development
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues. Provide regulatory guidance to product development teams for the planning and compilation of critical documentation relating to the development process associated with worldwide submission(s).
  • Represent the Company before EU and FDA regulatory authorities
  • Compile and author CTD document for submission to regulatory agencies, including premarket notification submissions and premarket approval applications
  • Secure any regulatory documentation including any licenses, listings, permits and import/export certificates, as required
  • Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities. Stay informed of new & revised regulations, and disseminate regulatory information as appropriate.
  • Responsible for the review and approval of promotional, advertising, and labeling items
     
  Location: Cranbury, New Jersey  (map)
View Description
Job Description:

Qualification and Experience:

BS/MS in Cell and Molecular Biology or equivalent. 

0-5 years of experience; must be comfortable multi-tasking and working independently in the laboratory; must be able to effectively communicate results and scientific information in a group or individual setting; must have basic knowledge of all Microsoft Office applications; must be flexible in executing and responding to changes in scheduling; must work well in a team environment.

Job Responsibilities:

  Cell and Molecular Biology (80%)

  • Participate in the planning and execution of experiments in molecular biology (construct creation, sequence verification, large-scale DNA preparation, etc.)
  • Participate in the planning and execution of experiments in cell biology (mammalian cell culture, cell line development, clone selection, cell-based assays, etc.)
  • Participate in the planning and execution of experiments in lab automation (FACS, Octet, etc.)
  • Maintain a current laboratory notebook with scientific rigor to meet project needs

    Culture (20%)

  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Present data or ideas in team meetings.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Other responsibilities may be assigned as required.

 

 

View Description
Job Description:

 

Qualification and 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.

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.
     

 

Job Requirements (skills required but not limited to)

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

 

Qualification and Experience:

  • BS/MS in Biochemistry/Biotechnology or related field.
  • 0-2 years of relevant experience.
  • Knowledge in protein chemistry.
  • Experience with wet chemistry method and analytical instrument method e.g. IR, UV, FLR, electrophoresis, HPLC, LC/MS and protein purification techniques preferred.
  • Motivation to be part of a high performance, diverse, and efficient scientific team.
  • Excellent spoken and written communication skills.
     

Job Responsibilities:

This position directly reports to the group leader of Protein Characterization and Quality Control with responsibilities including but not limited to:

   Sample analysis and method development of biologics (50%):

  • Conduct routine analytical testing in support of protein therapeutic products for antibody/protein primary structure characterization (amino acid sequence coverage analysis, molecular weight determination, amino acid composition analysis, cysteine conformation, free thiol contest), post translational modifications characterization, glycosylation characterization (N-glycans, monosaccharaides, sialic acid).
  • Conduct routine analytical testing for high order structure characterization (Light Scattering, differential scanning calorimetry, spectroscopy).
  • Responsible for data analysis, data report, data interpretation and data entry in ELN, Prepare lab document/protocols.
     

Support QC activities involving analysis of samples from Clinical Manufacturing Facility (40%)

  • Perform QC testing on the release (raw material and product), stability and in-process samples.
  • Document all QC related activities as disciplined by 21 CFR Part 11, 21 CFR Part 211 and ICH guidelines.
  • Assist in maintenance of cGMP related equipment.
  • Maintain up to date training records to establish competency in QC related assays.
     

  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:

Qualification and Experience:

PhD/MS/BS in Life Science, Chemical Engineering or equivalent

Minimum 5+ years of experience in absence of graduate degree, 2+ years if MS, or entry level PhD; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement.

Job Responsibilities:

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

Process Development (50%)

  • Plan and execute experiments performed to evaluate cell lines, culture media, feeding strategies and process conditions.
  • Work in collaboration with Operations group to execute protocols, experimental plans, critical production batches, and tech transfers.
  • Use designed experiments (DOE) to predict/understand/control the impact of process parameters on product quality (CQAs).
  • Represent functional area in team meetings as required.
  • Author experimental plans, reports, and operating procedures
  • Maintain a current laboratory notebook with scientific rigor to meet project needs for process development.
  • Implement state of the art science and technology with respect to media development, cell line development, primary recovery, and bioreactor systems while exploiting miniaturization to the fullest extent possible.
  • Collaborate with other function to deliver an efficient low cost solution to customers.
  • Support the transfer of processes to scale up/manufacturing sites.
  • Deliver desired performance using a range of industrially relevant feedstock’s and media components at lab and pilot scales (2 L - 2,000 L).
  • Work closely with the cell line development team to guide efforts toward scalable and robust culture processes.
  • Characterize and optimize processes, from a commercial scale perspective, through process development at lab and pilot scales to achieve established performance metrics and production cost targets for all products under development.
  • Develop effective mammalian scale-down capabilities and implement effective and scalable process control strategies.
  • Write technical reports, help developing SOPs and make oral presentations to summarize the results and investigations.
  • Follow standard operating procedures for laboratory duties, experiment design, data analysis and process monitoring
  • This position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position

Equipment and Facilities (30%):

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

Culture (20%):

  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Present data or ideas in team meetings.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Head of Upstream Development may assign other responsibilities as required.
  • Provide mentoring, coaching, training to others.
  • Demonstrated technical leadership skills
  • Good oral and written communication skills
  • Must be able to work productively in an interdisciplinary team environment
  Location: Offisite: 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 Display 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 objections in treating patient’s medical needs.

Qualifications & Experience

  • PhD in Biotechnology/Chemical Engineering/Biological Sciences, plus 5-10 years of program-leadership experience in biotechnology industry
  • Strong knowledge of scFv, antibody and biologic structure-activity relationships, stability and protein engineering/computer modeling
  • Experienced in phage panning including solution and cell based screening, Bioassays, ELISA, Octet/Biacore and Flow Cytometry /FACS
  • Knowledge of molecular biology, with recombinant DNA manipulation, PCR, cloning, subcloning using novel technologies such as E-Gels and Clonewell Technology
  • 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

 

JOB RESPONSIBILITIES

This position will report to the Vice-President of Discovery and Development Sciences with responsibilities including (but not limited to):

  • Oversee and lead/manage a portfolio of discovery biologics programs and the Discovery scientists including  PhD’s.
  • 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
  • Present and report research progress in individual meetings and group meetings in a professional manner, prepare project reports and project experimental timelines.
  • Critical-path management of scientific activities,  problem solving, and contingency planning
  • Experience with automated equipment and flexibility to learn and set up new equipment and novel technologies
  • Extensive experience with managing PhD level, MS level and BS level Scientists, ready to teach lab skills and explain theoretical concepts in a simplified manner to all level of Scientists
  • Plan for the proof of concept animal studies with lead-optimization activities

Support Company 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
View Description
Job Description:

 

Qualifications & Experience:

PhD/MS in Cell and Molecular Biology or equivalent

Minimum 5+ years of experience if MS or entry level PhD; must have demonstrated ability to design and evaluate experiments; must be comfortable multi-tasking and working independently in the laboratory; must be able to effectively communicate results and scientific information in a group or individual setting; must have basic knowledge of all Microsoft Office applications; must be flexible in executing and responding to changes in scheduling; must work well in a team environment; experience training others a plus; must have a strong focus on creativity and continuous improvement.

 

Job Description

This position will report to the Head of Cell and Molecular Biology with responsibilities including, but not limited to:

Cell and Molecular Biology (80%)

  • Design and/or participate in the planning and execution of experiments in molecular biology (construct creation, sequence verification, large-scale DNA preparation, etc.)
  • Design and/or participate in the planning and execution of experiments in cell biology (mammalian cell culture, cell line development, clone selection, cell-based assays, etc.)
  • Design and/or participate in the planning and execution of experiments in lab automation (FACS, Octet, etc.)
  • Participate in the teaching and training of fellow team members
  • Maintain a current laboratory notebook with scientific rigor to meet project needs
  • Author experimental plans and reports
  • Implement state of the art science and technology with respect to molecular biology and cell line development.

Culture (20%)

  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Present data or ideas in team meetings.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Other responsibilities may be assigned as required.
  • Must be able to work productively in an interdisciplinary team environment.
  • Head of Cell and Molecular Biology may assign other responsibilities as required.
  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:

BS in an Engineering discipline.   Minimum of 10 years of experience with demonstrated ability in facility operations, particularly HVAC.  The applicant should have a working knowledge in the principles of facility & equipment maintenance and environmental, health & safety (EH&S).  The applicant should have the skills to repair a malfunctioning piece of equipment such that the appropriate sub-contractor can be contacted.  The applicant shall have excellent communication skills that facilitate operations in cross functioning groups.

Job Description:

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 to the Director of Clinical Manufacturing with responsibilities including (but not limited to):

Research & Development and cGMP Equipment Maintenance (40%)

  • Play a lead role in the management of validation, maintenance and calibration programs supporting all equipment.
  • Set-up and advocate sub-contracting plan and network of approved vendors/ contractors required for specialized equipment services.
  • Make necessary repairs to equipment as needed.
  • Specify, coordinate, execute and oversee sub-contractors in the execution of maintenance, calibrations and repairs of equipment.
  • Implement an efficient system for tracking equipment calibration and maintenance history.

Research & Development and cGMP Facility Infrastructure (40%)

  • Maintain 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
  • Specify, coordinate, execute and oversee sub-contractors in the execution of modifications, maintenance and repairs of the existing facilities.
  • Serve as head of EH&S.
  • Serve as head of Security.
  • Implement an efficient system for tracking facility maintenance history.
  • Operate and maintain forklift.

Culture (20%)

  • Collaborate with all function heads to deliver efficient low cost solutions for maintenance of facilities and equipment.
  • Follow full cGMP guidance and fulfill all regulatory requirements at all times.
  • Execute and maintain all equipment and facilities in a safe and environmentally conscious manner.
  • Evaluate technologies and propose ideas for innovation.
  • Support business development activities as required.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Management team may assign other responsibilities as required.
  Location: Cranbury, New Jersey  (map)