Senior Manager Manufacturing

Overview

An experienced professional is sought to oversee commercial Contract Manufacturing Organizations (CMOs) and third-party suppliers, ensuring seamless product transfer from R&D/Product Development to commercial entities primarily within the EU, with potential global involvement. The role emphasizes maintaining manufacturing schedules, meeting internal and external needs, and upholding quality, budget, and profitability standards.

Key Responsibilities

• Develop and maintain strong relationships with contract manufacturers.
• Support the management of CMO contracts.
• Develop standard operating procedures (SOPs) and work processes for Commercial Manufacturing.
• Collaborate with CMOs to identify and resolve process issues.
• Evaluate and select CMOs for the production of commercial products.
• Collect and analyze metrics to measure CMO performance and lead CMO partnership teams.
• Work with the Quality Group to assess the impact of process deviations and pursue resolutions.
• Establish timelines, goals, and deliverables for API, Drug product, and related manufacturing processes.
• Optimize manufacturing processes to enhance product quality, efficiency, and cost-effectiveness.
• Assist in developing sourcing strategies for drug product and drug substance.
• Ensure CMOs comply with all Good Manufacturing Practice (GMP) requirements, guidelines, and procedures.
• Track deviations and process changes, collaborating with Regulatory Affairs and Quality Assurance to evaluate their impact 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 contract site preparation for regulatory inspections.
• Support interdisciplinary teams with recommendations, advice, and action plans for manufacturing issues.
• Provide onsite process coverage as needed.
• Develop and maintain compliance with import/export regulatory requirements.
• Effectively communicate manufacturing or technology-related issues to committees, teams, and stakeholders.
• Train and mentor personnel as required.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or a related field; Master's or Ph.D. preferred.
• 8+ years of progressively responsible experience within the pharmaceutical or biotechnology industry.
• Experience with contract service providers.
• Strong understanding of the biopharmaceutical drug development process, including regulatory filings and quality inspections.
• Extensive knowledge of post-approval manufacturing regulations and process changes.
• Willingness to travel domestically and internationally as required.