Job Description

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.

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.

Qualifications

• 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.
• A Successful hire will eventually have the opportunity to build own funded research program within the Formulation & Advanced Drug Delivery group.

Desired skill:

• Hands-on experience in oral dosage manufacturing and processing equipment
• Experience in developing novel long-acting intramuscular formulation platform

The salary range is: $69,888-$87,36042. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.