Associate Director, External Manufacturing

Merck • Sacramento, CA

1d • $129,000 - $203,100 • Remote

About The Position

The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate individuals to join our dynamic team! GPO is a diverse global organization committed to bringing a compliant, reliable supply of life-saving and affordable medicines to patients around the world. Our organization is responsible for the manufacturing and supply of all pharmaceutical products, packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving communities in more than 175 markets around the globe with more than 7 billion doses of vital medicine distributed each year. Collaborating with other operating units and functions, GPO's commitment to enhancing the patient experience and improving access to life-saving treatments is achieved through a network of internal and external sites that support the enterprise and division’s strategic priorities.
Our company's Small Molecule External Manufacturing organization is responsible for management of third party manufactures of our Company’s products across drug substance, drug product and packaging operations. The organization helps launch and supply our critical medicines and vaccines around the world. The role of the Integrated Launch Excellence (ILE) platform within the organization is focused on the introduction/demonstration/validation of new products at EPs.
External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and to integrating these EP into our company's supply chain appropriately and is the owner and primary point of contact for all interactions between our Manufacturing Division and EPs.
The successful candidate is responsible to establish boundaries and ground rules for engagement with the EPs, while ensuring compliance/quality readiness of these suppliers at all times through the implementation of risk assessments and frequent walkthroughs. The number of EPs an Ops AD is accountable for will depend upon factors such as: product type, size and/or complexity of supply agreement, geography, etc.; however will typically manage relationships that are highly complex in nature and of strategic importance.
This role will support management of critical site(s) in the U.S. for the Integrated Launch Excellence team. The number of sites an Ops AD is accountable for will depend upon factors such as: product type, size and/or complexity of supply agreement, geography, etc..

Requirements

• No less than eight (8) years combined experiences in commercial/business and manufacturing (operations, project management, or quality, technology, supply chain etc.) function in pharmaceutical, chemical or related industry required (or equivalent combination of education/experience)
• Knowledge of Drug Substance manufacturing, including common unit operations and shop floor activities.
• Must possess excellent interpersonal, communication, project management, collaboration, negotiation, analytical and influencing skills
• Has demonstrated strong leadership in a teamwork environment and with strong team coordination abilities
• Cultural awareness and sensitivities
• Fluency in English both verbal and written

Nice To Haves

• Recent ExM Operations or site operations
• Conversant on domestic and foreign regulations and compendia governing manufacturing operations
• Lean project implementation
• Strong influencing skills demonstrated at various levels

Responsibilities

• Dispute resolution with appropriate escalation
• Balancing our company's delivery requirements with contract manufacturer’s production plan.
• Materials Management (ERP transactions, Logistics)
• Oversight of shop floor production (determining when an ExM functional rep should be deployed to the contract manufacturer’s facility)
• Continuous Improvement activities
• Partners with Procurement in the Identification/Selection of new contract manufacturers and Negotiation/Termination of Supply Agreements, as required
• Facilitates the collection of contract manufacturer’s capacity information (e.g. stated capacity, firm capacity, future capacity plans, time horizon/lead times required, comments/concerns, etc.), presents the information to Supply Chain Management and drives recommendations for capacity expansion at contract manufacturers, as required
• Ensuring alignment of the Supply and Quality agreements
• Executing ERP transactions associated with receipt and movement of company owned inventory, book-to-physical reconciling of company owned inventory at contract manufacturers, and documenting and witnessing destruction of company owned inventory
• Ensuring contract terms agreed upon by our company and the contract manufacturer including, but not limited to, purchase orders, forecasts, deliveries, and invoice payments are executed in compliance with the Supply Agreement
• Partners with the ExM Company Production System experts and other functionalities supporting ExM (e.g. technical, quality, procurement, etc.) to identify continuous improvement opportunities at contract manufacturers and supports
• Project management support to the DP NA regional team, and to ensure a greater coordination of ongoing projects within the region

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager