Blossoming CDMO is looking to bring on MULTIPLE QC leaders including a Sr QC Manager focusing in Analytical Chemistry. With room to grow, an opportunity with this company is one you don't want to miss!
Responsibilities:
- Oversee testing activities: raw material, component, drug product, stability, validation, investigational, in-process testing, etc.
- Serve as a subject matter expert for analytical testing
- Ensure the laboratories are clean, organized, compliant, and audit ready at all times.
- Support formulation, process development, and scale-up activities
- Review and approve analytical data for accuracy and completeness
- Lead and serve on cross-functional project teams
- Prepare protocols ,technical reports, and other documentation for CMC related activities
- Ensure compliance of laboratory personnel and equipment
- Prepare annual laboratory budgeting
- Perform annual performance assessments of direct reports
Preferred Qualifications:
- Bachelor's Degree in chemistry, biology, or related science
- 4+ years of experience in a pharmaceutical laboratory management role.
- Must possess strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, analytical testing techniques, and cGMP.
