What are the responsibilities and job description for the Tech Operations Manager position at Advanced Clinical?
Key Responsibilities
- Support process change activities for drug substances, intermediates, and raw materials
- Lead or support investigations and resolve discrepancies in a timely manner
- Partner with DS manufacturing teams to understand capabilities, capacity, and constraints at CMOs; develop plans to secure capacity as needed
- Provide technical oversight during GMP manufacturing campaigns
- Collaborate with Quality Assurance, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure alignment on timelines and deliverables
- Develop strong technical documentation and apply analytical problem-solving skills
- Work independently with minimal guidance
- Bachelor’s degree in Science, Engineering, Operations, or a related field
- 8 years of experience in drug substance (DS) manufacturing or development environments
- Experience with lifecycle management for commercial products
- Strong knowledge of Good Manufacturing Practices (GMPs)
- Demonstrated ability to exercise sound judgment and make appropriate decisions for the organization
- Results-driven with initiative and ownership to accomplish work
- Flexible and adaptable to change in a dynamic, rapidly growing environment
