Postdoc, Formulation Science

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

Desired Skills

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

Pay

The salary range is: $69,888-$87,360. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles.

Benefits

SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/.