Job Title: Senior Manager, Manufacturing
The Senior Manager, Manufacturing, will oversee commercial Contract Manufacturing Organizations (CMOs) and other third-party suppliers for selected products. This role primarily focuses on the transfer of processes from R&D/Product Development to commercial suppliers, primarily within the EU, but may also encompass other global regions. The individual will manage ongoing manufacturing schedules to ensure that both development and commercial supply levels are maintained while meeting inventory targets. A key focus of this role is to ensure that manufacturing activities satisfy the needs of all internal and external stakeholders, emphasizing process efficiency, quality, budget control, and profitability.
Primary Responsibilities:
- Develop and maintain strong working relationships with contract manufacturers.
- Support the management of CMO contracts.
- Develop Standard Operating Procedures (SOPs) and work processes required for commercial manufacturing.
- Collaborate with CMOs to diagnose and rectify process issues.
- Identify, evaluate, and select CMOs for the manufacture of commercial products.
- Develop and collect appropriate metrics to measure CMO performance and lead CMO partnership teams.
- Work with the Quality Group to assess the impact of process deviations and drive resolutions.
- Establish timelines, goals, and deliverables for Active Pharmaceutical Ingredient (API), Drug Product, and associated manufacturing processes.
- Optimize manufacturing processes to maintain high product quality, enhance process portability, increase robustness, improve efficiency, and reduce costs.
- Assist in developing sourcing strategies for drug products and drug substances.
- Collaborate with Quality Assurance to ensure CMOs remain compliant with all Good Manufacturing Practice (GMP) requirements, guidelines, and procedures.
- Track deviations and process changes for different suppliers, collaborating with Regulatory Affairs and Quality Assurance to assess their impact on regulatory submissions.
- Initiate and coordinate the preparation of CMC (Chemistry, Manufacturing, and Controls) documentation as required.
- Partner with Regulatory Affairs and other departments to support product filings.
- Assist in contract site preparation for regulatory inspections.
- Support cross-functional teams with recommendations, advice, and action plans for manufacturing-related issues.
- Provide on-site process coverage as necessary.
- Develop systems and maintain compliance with import/export regulatory requirements.
- Communicate manufacturing or technology-related issues and information effectively to committees, teams, and interested parties within the company.
- Train and mentor personnel as required.
Education/Experience/Skills:
A Bachelor’s degree in Engineering, Chemistry, or a related field is required, with a Master’s or Ph.D. preferred. The ideal candidate will have a minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology industry.
Must Possess:
- Experience with contract service providers.
- A strong understanding of the biopharmaceutical drug development process, including regulatory filings and quality inspections.
- Extensive knowledge of regulations pertaining to post-approval manufacturing process changes and site modifications.
- Willingness to travel domestically and internationally as required for this role.
To apply, please fill out the form below. Only applications matching the job profile will be considered.