Job Details
Meet s innovative and fast-growing client has engaged us on an exciting new search for a talented Quality Control Manager. You will be responsible for leading QC in partnering with CDMOs to meet testing timelines and support overall processes across sample management, documentation, and compliance. You will have the opportunity to join a growing biotech organization with a robust pipeline of vaccines to combat infectious diseases across the globe. They are well-funded and offer comprehensive benefits.
Job Overview:
- Partner with CDMO vendors to ensure release testing deliverables are met, reviewing and approving analysis documentation including SOPs
- Applying knowledge and experience in method validation/testing/release, managing sample forms and shipping activities with CMOs
- Reviewing deviations and conducting investigations for change control, besides supporting audits and inspections
- Supporting a culture of continuous improvement and partnering with key stake holders both internally and externally
Requirements:
- MS or BS with 7+ years of relevant industry experience leading Quality Control with internal biopharma and external CDMOs
- Strong understanding of analytical chemistry principles across method transfer, validation, release testing - preferably in proteins, conjugate molecules or other large biologics
- Expertise in technical writing across analytical and QC documentation including working knowledge of regulatory standards across the globe
Contact:
- Please reach out to Brandon Weber at 646-###-#### or ...@peoplewithchemistry.com to learn more. Correspondence will be confidential.