Job Description

POSITION: Scientist, Bioassay Analytical Development COMPANY: Biotechnology LOCATION: Brisbane, California BENEFITS: Medical, Dental, Vision, 401k, Sick Pay

JOB SUMMARY

Growing Biotechnology company is seeking a Scientist to be part of our Analytical Development Group within Technical Operations to support the development of our Adeno-associated virus (AAV) gene therapy products and gene-edited cellular therapies. In this role, the candidate will develop and qualify new bioassay analytical methods to enable a variety of cell and gene therapy development programs. This is a laboratory-based position that requires creativity, organization, attention to detail, excellent communication and presentation skills, and a capacity for constant innovation in pursuit of company goals. The ideal candidate will be experienced in using immortalized cells to develop cell-based relative potency assays for all phases of clinical development and have a fundamental understanding of ICH guidelines for method qualification. The environment is exciting, fast-paced, and offers the opportunity to work at the cutting edge of cell and gene therapy.

RESPONSIBILITIES

• Independently design, plan, and execute cell-based potency assays, and infectivity assays, evaluate emerging technologies, and qualify and transfer studies to support the release, stability, and characterization of AAV and/or lentivirus in-process, drug substance, and drug product.
• Work independently on cell culture aspects, including but not limited to cell passage and making of the master cell banks and working cell banks of adherent and suspension cells.
• Perform trend analysis to monitor the performance of an assay over time.
• Independently analyze, interpret, provide conclusions, and present experimental data at interdepartmental meetings.
• Collaborate with Upstream/Downstream Process functions, Formulation, and Quality control departments.
• Creating electronic documentation for each task, including cleaning procedures, aseptic processing techniques, and other assay-related steps in a contemporaneous manner.
• Contribute to the completion of milestones associated with specific project plans.
• Participate in team activities such as routine laboratory organization of samples and reagents and maintenance of lab equipment.

QUALIFICATIONS

• Ph.D. in Biological Sciences such as Molecular Biology, Immunology, Virology, or related discipline.
• 2-5 years of experience in mammalian cell culture, infectivity assays, Cell-based assays, immunoassays, FACS analysis, Molecular biology, and Biochemistry techniques is essential.
• Experience in statistical analysis software such as JMP, SoftMax Pro, and GraphPad Prism, and fluency in electronic lab notebook documentation preferred.
• An understanding of USP/ICH guidelines for analytical method development, qualification/validation is a strong plus.

THE OPPORTUNITY/MORE INFORMATION

• Great stepping stone opportunity to build career in the cella and gene therapy industry
• Healthy pipeline of cell and gene therapy programs offering many learning opportunities and growth track
• Team size: 5-8 staff members who are collaborative, communicative, supportive and eager to help you succeed
• Soft skills desired: self starter, eager to learn, good communication skills
• Opportunity to work in a small team for relationship building
• Excellent leadership who are constantly empowering employees to grow
• Work in a beautiful state of the art atrium style building with panoramic views of the San Francisco Bay Area oceanfront
• Free Parking, Bicycle Rack Station, Electric Car Charging Stations, Shuttle Service to and from Balboa Park Station BART
• Free lunch on Tuesdays and Tuesdays, coffee, soda, snacks, and subsidized meals