Associate Director, External Manufacturing Operations

Merck Associate Director, External Manufacturing Operations Honolulu, Hawaii Apply Now

An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.

You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.

You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are accountable for delivering daily / weekly / monthly / annual requirements at their external partner(s).

Bring energy, knowledge, innovation to carry out the following :

• Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w / appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production.
• Maintain a virtual presence at external partners site on the production floor either virtually or physically; build a strong co-dependent relationship with the sites leadership team.
• Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship.
• Participate in and represent External Manufacturing on cross-functional teams for due diligence ahead of siting approval & post siting approval.
• Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI.
• Accountable for maintaining the integrity of the Master Supply Agreement.
• Act as our Company operational excellence leader & coach for own team.
• Lead with the Virtual external partner periodic Business and Operations Review Meetings.
• Participate in the creation and maintenance of an External Manufacturing Organization Handbook.

Minimum Qualifications :

Required experience and skills :

Minimum 8 years’ experience in commercial / business and manufacturing (sterile operations, quality, technology, planning). Role requires a portion in management / leadership positions or project management. At least two (2) years of experience in management / leadership positions.

Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.

Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.

Possess excellent interactive, communication, partnership and negotiation skills.

Direct Health Authority Audit experience is desirable.

J-18808-Ljbffr