Principal Scientist

Analytical Chemist - Quality Control

Duration: 5-month contract

Remote in California

Responsibilities:

• Be a recognized subject matter expert in support of late-phase product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of drug substances and drug products.
• Provided technical guidance for troubleshooting/investigating complex analytical issues. Quickly and effectively resolved complex analytical issues and deviation/investigations.
• Collaborate with cross-functional technical operations, quality, and regulatory CMC partners to deliver on the integrated program CMC strategy.
• Lead the development of robust analytical control strategies to support process scale-up, validation, and commercial manufacturing, apply knowledge and direct experience to ensure the appropriate methodologies are in place and the methods are validated in accordance to the regulatory guidelines.
• Provide technical input for selecting external contractors and manage day-to-day analytical activities for the respective projects.
• Design, support, and analyze method transfer and validation activities across a late-phase portfolio of small molecules
• Author and review CMC sections of regulatory submissions and lead responses to questions and requests for additional information
• Identify and advocate for new and emerging technologies in analytical and physical characterization analysis

Qualifications:

• 10-15 years of GMP / QC experience in small molecule API and sterile, lyophilized DP
• Be a recognized subject matter expert in support of late-phase product development
• Apply broad and deep analytical knowledge and experience to the testing of small molecule drug substances and sterile, lyophilized drug products.
• Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment.
• Strong organizational, project management, and communication skills, both verbal and written.