Job Title: Senior Manager, Manufacturing
The Senior Manager, Manufacturing, is accountable for overseeing commercial Contract Manufacturing Organizations (CMOs) and various third-party suppliers for designated products. This role includes supervising the transfer of processes from R&D/Product Development to commercial suppliers, primarily within the EU, though it may extend to other global regions. This position is critical to maintaining development and commercial supply levels while achieving inventory targets. Emphasizing process efficiency, quality, budget control, and profitability, the Senior Manager ensures that manufacturing activities align with the needs of all stakeholders.
Primary Responsibilities:
- Develop and nurture strong working relationships with contract manufacturers.
- Support the management of CMO contracts.
- Develop Standard Operating Procedures (SOPs) and work processes essential for Commercial Manufacturing.
- Collaborate with CMOs to diagnose and resolve process issues.
- Identify, evaluate, and select CMOs for the manufacture of commercial products.
- Develop and collect metrics to assess CMO performance; lead CMO partnership teams.
- Work with the Quality Group to analyze the impact of process deviations and seek resolutions.
- Establish timelines, goals, and deliverables for API, drug product, and related manufacturing processes.
- Optimize the manufacturing process to enhance product quality, improve process portability and robustness, increase efficiency, and lower manufacturing costs.
- Assist in formulating drug product and drug substance sourcing strategies.
- Ensure CMOs remain compliant with all GMP-related requirements, guidelines, and procedures in collaboration with Quality Assurance.
- Track deviations and changes in processes among suppliers, coordinating with Regulatory Affairs and Quality Assurance to evaluate their impact on regulatory filings.
- Initiate and coordinate the preparation of CMC documentation as needed.
- Collaborate with Regulatory Affairs and other departments to support product filings.
- Assist in contract site preparations for regulatory inspections.
- Support interdisciplinary teams with recommendations, advice, and action plans for manufacturing-related issues.
- Provide onsite process oversight as necessary.
- Develop and maintain compliance with import/export regulatory requirements.
- Communicate manufacturing or technology-related issues to committees, teams, and stakeholders within the company.
- Train and mentor personnel as required.
Education/Experience/Skills:
A Bachelor’s degree in Engineering, Chemistry, or a relevant field is required; a Master's or Ph.D. is preferred. The position requires a minimum of 8 years of progressively responsible experience in the pharmaceutical or biotechnology industry.
Key qualifications include:
- Experience with contract service providers.
- A strong understanding of the biopharmaceutical drug development process, including regulatory filings and quality inspections.
- Extensive knowledge of regulations regarding post-approval manufacturing process changes and site modifications.
- Willingness to travel domestically and internationally as required.
Apply online using the form below. Only applications matching the job profile will be considered.