Postdoc, Formulation Science
About The Position
SRI’s Biosciences Division (BSD) develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the breadth — and depth — to deliver the latest in biomedical research through technology development. Our researchers have a rich legacy of collaboration with government agencies and industry partners that improve health outcomes and well-being around the world. SRI Biosciences projects range from high-impact, early-stage research to drug co-development with pharmaceutical and biotech companies. BSD's Center for Pharmaceutical Sciences is seeking a Postdoctoral Fellow /formulation scientist to be a part of the Formulation & Advanced Drug Delivery group. The successful candidate will design and develop pre-clinical stage candidate formulations for the delivery of small molecules/proteins/vaccines/antibodies. Candidate will actively collaborate with analytical and quality control, pharmacokinetics and toxicology, clinical manufacturing and quality assurance, as needed, throughout the various stages of the project. The Postdoc position will work onsite in our Menlo Park, CA office.
Requirements
- A Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biomedical Engineering or related fields
- 3+ years of hands-on experience in pharmaceutical formulation, product development, or a related R&D environment.
- In-depth knowledge of formulation and biopharmaceutical development, protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or analytical and comparability testing strategies.
- Strong understanding of Good Manufacturing Practices (GMP) and FDA regulatory requirements.
- Candidates should be able to work both independently and as part of a multidisciplinary team.
- Excellent written and oral communication skills are required.
Nice To Haves
- Hands-on experience in oral dosage manufacturing and processing equipment
- Experience in developing novel long-acting intramuscular formulation platform
Responsibilities
- Development, tech-transfer and clinical manufacturing of injectable, oral and topical formulations
- Generate & analyze data and results and contribute to the recommendations for next steps based on the data.
- Generate pre-formulation and formulation technical reports, as well as technology transfer reports.
- Establish the basis of formulation and manufacturing process with relevant attributes and specifications as required to achieve the goal.
- Provide support for analytical development through the Product development cycle.
- Collaborate with manufacturing teams to transition formulations from laboratory scale to pilot and full commercial production.
- Prepare batch records, technical reports, and regulatory documentation in strict compliance with cGMP guidelines
- Author and review development and production reports and CMC sections of regulatory submissions.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
- Report and present scientific/technical results internally and to external clients
- Contribute to internal research and intellectual property projects and initiatives.
Benefits
- competitive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
