Direct message the job poster from GForce Life Sciences
Fiona Bushe
Associate MSP Recruiter at GForce Life Sciences
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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance, Science, and Research
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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