General Summary Provide analytical support and cell culture technical expertise for GenCure Biomanufacturing Center (GBC) Process Development and Manufacturing including: analytical methods development and tech transfer, transition of analytical methods for cGMP/QC testing as well as managing relationships with outside vendors and Contract Research and Testing Organizations. This position requires strict attention to detail and high quality customer service skills.
Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).
Major Duties and Responsibilities Under guidance of the Process Development Team Lead, with expectations for exercising independent technical judgment, specific responsibilities will include:
- Lead efforts in the development and phase-appropriate validation of analytical test methods for the characterization and release testing of cell therapy clinical materials. Independently manage technology transfer of research analytical methods by collaborating with client technical teams. Following approved technology transfer protocols; this person will optimize existing methods and validate them as appropriate for QC release testing. This includes generation of all relevant documentation.
- Following FDA GMP regulations and guidelines, this individual will collaborate in the clinical-scale GMP manufacturing, in process testing and QC release testing of cell therapy products. This will include operational scheduling of various activities; including analytical/QC supply procurement, product testing, facility cleaning and environmental monitoring, calibration, preventative maintenance and validation activities.
- Manage relationships with outside analytical supply vendors and contract testing laboratories, as appropriate. Establish and maintain relationships with technical representatives concerning testing of clinical trial materials.
- This individual will be responsible for authoring all relevant technical reports detailing analytical methods transfer, testing of development batches, preclinical safety/toxicology batches and GMP-grade clinical batches.
- Provide cell culture expertise to GBC Manufacturing Team as needed, for cGMP manufacture of Cell Banks, Final Cell Product, Extracellular Vesicles, etc.
- PhD or Master’s degree (minimum of 5 years of experience) in a scientific or engineering discipline is required with experience in mammalian cell culture, analytical cell biology and analytical biochemistry.
- Experience in all aspects of mammalian cell culture and stem cell characterization (ELISA, Flow cytometry, PCR, microbiology testing and control, viral testing and control, differentiation, enzyme assays, etc).
- Experience in cGMP principles, Quality Management Systems and cGMP analytical testing is desired.
Must have a working knowledge of tissue and cell culture.
Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.
Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations.
Must have a specific understanding of two or more of the following subject matter areas is strongly preferred: wound healing biology, bone biology, cell-based therapeutics and/or applied regenerative medicine.
Must have excellent hands-on laboratory skills.
Must have excellent interpersonal and public speaking skills.
Must demonstrate the ability to solve technical and/or clinical problems with biotechnology-based solutions required.
Must be able to commit to project delivery timelines and budget.
Must be able to keep information confidential.
Must be energetic, enthusiastic and have a team-oriented leadership style.
Must be neat in appearance and well groomed.
Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
Must maintain a good working rapport with co-workers.
Works in a well-lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend.
Will sit, stand, walk, and bend during working hours.
Requires manual and finger dexterity and eye-hand coordination.
Required to lift and carry relatively light materials.
Requires normal or corrected vision and hearing corrected to a normal range.