Scientist - Manufacturing, T-cells, cell culture, bioreactors in South San Francisco, CA at Apex Life Sciences

Date Posted: 2/12/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a highly motivated, results-oriented, self-starter to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes. The successful candidate will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO. 

Responsibilities:

  • Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
  • Support clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including Tech Transfer to CMO and support of successful GMP manufacturing of clinical material.
  • Contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection and cell engineering strategies, media development, disposable/ closed production systems and automation), aligned with emerging business drivers and Regulatory expectations.
  • Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups 
  • Demonstrate strong “personal leadership”/ accountability and technical and interpersonal skills, and apply scientific and technical experience to ensure safe, high-quality lab practices
  • Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
  • Present data/ strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.

Requirements:

  • BS or MS degree in Molecular Immunology/ Molecular Biology, Bioengineering, or related degree (with appropriate cell and gene therapy focus)
  • 3+ years (1+ for MS) of experience in biotech/biopharma industry (preferably in the development and characterization of manufacturing processes for cell- or gene-based therapies).
  • Process development for GMP manufacturing of cell- or gene-therapies
  • Culture and characterization of primary T-cells, T-cell molecular biology/ engineering
  • Aseptic cell culture technique
  • Direct experience with T-cell activation, viral transduction, and mRNA electroporation is highly desirable
  • Familiarity with cGMP and relevant Regulatory Guidance documents a plus
  • Familiarity with single-use bioprocessing such as WAVE bioreactors and CliniMACS Prodigy a plus
  • Experience with process scale-up and scale-down is desired
  • Knowledge with Design of Experiments a plus

***For immediate consideration, please email your updated resume to sbertoli@apexlifesciences.com with 'Scientist - manufacturing processes' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.