Job Opening: Senior Manager, Manufacturing
We are seeking a Senior Manager of Manufacturing who will oversee commercial Contract Manufacturing Organizations (CMOs) and various third-party suppliers for select products. This role focuses on managing the transfer of processes from R&D and product development to commercial third-party suppliers, primarily within the EU but potentially extending to other global locations. The Senior Manager will ensure that ongoing manufacturing schedules align with development and commercial supply levels while meeting inventory targets. A critical aspect of this role is to ensure that manufacturing activities satisfy the requirements of all internal and external stakeholders, with a strong emphasis on process optimization, quality control, budget management, and profitability.
Primary Responsibilities:
- Develop and maintain productive relationships with contract manufacturers.
- Support the management of CMO contracts.
- Develop Standard Operating Procedures (SOPs) and workflows essential for commercial manufacturing.
- Collaborate with CMOs to identify and resolve process issues.
- Identify, evaluate, and select CMOs for the manufacture of commercial products.
- Gather and analyze metrics to assess CMO performance; lead CMO partnership teams.
- Work with the Quality Group to evaluate the impact of process deviations and develop resolutions.
- Create timelines, goals, and deliverables for API, drug product, and related manufacturing processes.
- Optimize manufacturing processes to ensure high product quality, enhance process portability, and improve efficiency while reducing costs.
- Assist in developing sourcing strategies for drug products and drug substances.
- Collaborate with Quality Assurance to ensure CMOs comply with all GMP-related requirements, guidelines, and procedures.
- Track deviations and process changes among suppliers; cooperate with Regulatory Affairs and Quality Assurance in evaluating their effects on regulatory filings.
- Initiate and coordinate the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation as required.
- Collaborate with Regulatory Affairs and other teams to support product filings.
- Assist in preparation activities for regulatory inspections at contract sites.
- Support interdisciplinary teams with recommendations, advice, and action plans concerning manufacturing-related challenges.
- Provide onsite process coverage as needed.
- Develop systems and maintain compliance with import/export regulatory requirements.
- Communicate manufacturing or technology-related issues and information to committees, teams, and stakeholders within the company.
- Train and mentor personnel as required.
Education, Experience, and Skills:
Bachelor's degree in Engineering, Chemistry, or an equivalent combination of relevant education and professional experience is required. A Master's degree or Ph.D. is preferred. The ideal candidate should have 8+ years of progressively responsible experience within the pharmaceutical or biotechnology industry.
Key Requirements:
- Experience with contract service providers.
- In-depth understanding of the biopharmaceutical drug development process, including regulatory filings and quality inspections/audits.
- Comprehensive knowledge of regulations relating to post-approval manufacturing process changes and site modifications.
- Domestic and international travel is required for this role.
Apply online using the form below. Only applications matching the job profile will be considered.