Our client is a biopharmaceutical company launching its EU operations.

Description

The Director of Manufacturing is the Business lead, Technical Lead and primary contact responsible for managing the company's commercial Drug Product (DP) Contract Manufacturing Organizations (CMO's), and other third-party suppliers. This position will also oversee the tracking of ongoing manufacturing, implementing process improvements, completion of quality investigations, and ensure commercial supply levels are maintained. The position will be responsible ongoing technical and business evaluation of the global manufacturing network.

Role will be a hands on and leadership role.

Primary Responsibilities

• Leads manufacturing activities and coordinating activities across a matrix team. A subject matter expert (SME) in DP manufacturing with extensive knowledgeable in development, quality, and regulatory requirements for manufacturing.
• Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc.), including oversight of manufacturing operation, managing deviations, investigations, and relevant change actions, supporting product release, and ensuring the finished product arrives in warehouse for distribution.
• Responsible for DP vendor selection process for new commercial suppliers or alternative suppliers.
• Develops and maintains good working relationships with contract manufacturers.
• Develops and maintains DP manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
• Coordinates periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
• Maintains and follow through a consolidated company Manufacturing action log to ensure all manufacturing related actions are completed on time.
• Provides onsite process coverage as person-in-plant as needed.
• Develops, collects appropriate internal and external metrics to measure CMO and the company performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
• Supervise, train and mentor personnel as needed.
• Prepare Annual Product Reports with Manufacturing CMOs according to the company's needs.
• Work with CMOs and internal colleagues to schedule and coordinate Steering Committee Meetings.
• Works with Quality and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Other duties as assigned.

Profile

• English Required. French and German preferred.
• Experience with new product introductions in EU required
• Small molecule experience required
• Bachelor's degree in Engineering, Chemistry or related field. MBA preferred.
• Targeting 10-12 years of progressively responsible experience within the pharmaceutical, biotech, or equivalent industry.
• An equivalent combination of relevant education and experience may be considered.
• Contract service provider experience.
• Strong understanding is required of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
• Strong business acumen.
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.

Job Offer

Great opportunity to join a growing company!