Associate Director, Manufacturing

Position Summary:

Responsible for oversight of commercial Contract Manufacturing Organizations (CMO’s), and other third-party suppliers for products as identified, including the transfer of processes from R&D/Product development to commercial third-party suppliers. Responsible for oversight of ongoing manufacturing schedules to ensure both development and commercial supply levels are maintained, and inventory targets are met. Ensures that manufacturing activities meet the needs of all internal and external constituencies with an emphasis on process, quality, budget control and profitability.

Primary Responsibilities:

• Develops and maintains good working relationships with contract manufacturers.


• Negotiate and manage CMO contracts


• Develops SOP’s and work processes needed for Commercial Manufacturing


• Works with CMOs to diagnose and correct process issues.


• Identifies, evaluates and selects CMOs for the manufacture of Commercial products


• Develops, collects appropriate metrics to measure CMO performance; leads CMO partnership teams.


• Works with Quality Group to determine the impact of process deviations and works towards resolutions


• Develops timelines, goals, and deliverables for API and related manufacturing processes.


• Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs.


• Assists in developing drug substance sourcing strategies.


• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.


• Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.


• Initiates and coordinates the preparation of CMC documentation as required


• Collaborates with Regulatory Affairs and other groups to support product filings.


• Assists in contract site preparation activities for regulatory inspections.


• Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.


• Provide onsite process coverage as person-in-plant as needed


• Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.


• Supervise, train and mentor personnel as needed.

Education/Experience/Skills:

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Master's or Ph.D. preferred.    A minimum of 10 years of progressively responsible experience within the pharmaceutical/biotechnology industry with 6 years in a leadership role.

Must possess:

• Contract service provider experience.


• Understanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits.


• Extensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc.


• Frequent travel to global manufacturing sites in the EU and Asia is required for this role

Scope:

Participate in strategic plans for designated function(s) and may participate with senior management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact on the long-term success of the company.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 50% of the time both domestically, internationally, and work after hours if required by travel schedule or business issues.