Associate Director, Manufacturing

h3Primary Responsibilities: /h3 /h3 ul liDevelops and maintains good working relationships with contract manufacturers. /li liNegotiate and manage CMO contracts /li liDevelops SOP’s and work processes needed for Commercial Manufacturing /li liWorks with CMOs to diagnose and correct process issues. /li liIdentifies, evaluates and selects CMOs for the manufacture of Commercial products /li liDevelops, collects appropriate metrics to measure CMO performance; leads CMO partnership teams. /li liWorks with Quality Group to determine the impact of process deviations and works towards resolutions /li liDevelops timelines, goals, and deliverables for API and related manufacturing processes. /li liOptimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs. /li liAssists in developing drug substance sourcing strategies. /li liWith Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures. /li liTracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings. /li liInitiates and coordinates the preparation of CMC documentation as required /li liCollaborates with Regulatory Affairs and other groups to support product filings. /li liAssists in contract site preparation activities for regulatory inspections. /li liSupports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues. /li liProvide onsite process coverage as person-in-plant as needed /li liCommunicates manufacturing or technology related issues and information to committees, teams and interested groups within the company. /li liSupervise, train and mentor personnel as needed. /li /ul h3Education/Experience/Skills: /h3 pBS 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. /p pMust possess: /p ul liContract service provider experience. /li liUnderstanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits. /li liExtensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc. /li liFrequent travel to global manufacturing sites in the EU and Asia is required for this role /li /ul h3Scope: /h3 pParticipate 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. /p h3Physical Requirements: /h3 pWhile 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. /p p pstrongWhat we offer US-based Employees: /strong /p ul liCompetitive base, bonus, new hire and ongoing equity packages /li liMedical, dental, and vision insurance /li liEmployer-paid life, disability, business travel and EAP coverage /li li401(k) Plan with a fully vested company match 1:1 up to 5% /li liEmployee Stock Purchase Plan with a 2-year purchase price lock-in /li li15+ vacation days /li li13 -15 paid holidays, including office closure between December 24th and January 1st /li li10 days of paid sick time /li liPaid parental leave benefit /li liTuition assistance /li /ul pstrong /p /p