Senior Manager, Manufacturing

• Develops and maintains good working relationships with contract manufacturers.
• Support the management of CMO contracts
• Develop SOP’s and work processes needed for Commercial Manufacturing
• Works with CMOs to diagnose and correct process issues.
• Identifies, evaluates and selects CMOs for the manufacture of Commercial products
• Develops, collects appropriate metrics to measure CMO performance; leads CMO partnership teams.
• Works with Quality Group to determine the impact of process deviations and works towards resolutions
• Develops timelines, goals, and deliverables for API, Drug product and related manufacturing processes.
• Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs.
• Assists in developing drug product and drug substance sourcing strategies.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
• Initiates and coordinates the preparation of CMC documentation as required
• Collaborates with Regulatory Affairs and other groups to support product filings.
• Assists in contract site preparation activities for regulatory inspections.
• Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.
• Provide onsite process coverage as person-in-pant as needed
• Develops systems and maintain compliance to import / export regulatory requirements.
• Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
• Train and mentor personnel as needed.

Education / Experience / Skills :

BS in Engineering / Chemistry or equivalent combination of relevant education and applicable job experience. Masters or Ph.D. preferred. Requires 8+ years of progressively responsible experience within the pharmaceutical / biotechnology industry.

Must possess :

• Strong understanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits.
• Extensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc.
• Domestic and Overseas Travel is required for this role.