What are the responsibilities and job description for the Senior Manager, Biologics Manufacturing & Supply position at Talent Groups?
đź“Ť Location: Remote - Harmans, MD (Travel required)
đź“… Duration: 6 months contract
Job Summary:
Seeking an experienced Sr. Manager to oversee manufacturing operations at a CMO site, ensuring clinical and commercial drug supply needs are met. The role involves direct onsite support, issue resolution, quality oversight, and collaboration with cross-functional teams.
Key Responsibilities:
- Support GMP (upstream/downstream) production at CMO partners.
- Serve as Person-in-Plant (PIP) for process/equipment-related issues.
- Review and author quality system documentation (deviations, change controls, reports).
- Lead investigations for major/critical deviations.
- Collaborate with Process Development & Quality for tech transfer and process validation.
- Ensure compliance with contractual obligations, timelines, and quality standards.
Qualifications:
- 8 years in biologics/gene therapy manufacturing or development.
- Strong knowledge of FDA regulations (GMPs) and industry standards.
- Excellent project management & communication skills.
- 20% travel required.
Apply today to make an impact in gene therapy manufacturing!
