Assoc. Dir, External Manufacturing

Job Description

Job Description: 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 around the world. This position is in  the integrated Launch Excellence (ILE) team which is the team in External Manufacturing responsible for delivering pipeline of new products. The Associate Director of External Manufacturing Operations, based in India,  will be required to manage the introduction of new products (Raw materials, intermediates & APIs) into third party manufacturers based in the Asia Pacific region. The incumbent will be required to manage the working relationship between stakeholders and third party manufacturers  to ensure effective delivery of our pipeline.  The incumbent will also work with strategic partners to ensure readiness to meet future pipeline needs. Primary activities during New Product Introduction projects include, but are not limited to:

• Involvement in Sourcing and product siting activities
• Completion of  due diligence of potential new third party manufacturers
• Developing and managing the overall new product introduction project plan with the third party to ensure all milestones are met to support launch timelines.
• Coordinating the cross functional Project team day to day working with the third party through the pre-execution, execution and post-execution phases of the project
• Managing operational project details with third party project manager eg: materials & equipment  readiness, documentation lifecycle, PIP (Person In Plant) planning, shipping & logistics including transactional support.
• Supporting PIP (Person In Plant) as required.
• Managing cross functional Project team stage-gate reviews with management
• Managing any scope changes during the project, evaluating impact, communicating and receiving endorsement for proposed changes.Â
• Coordinating risk management process through the project lifecycle.Â
• Event Management (Evaluation, impact assessment, Coordination of response, communication, escalation)
• Coordination of After Action Reviews with cross functional and third party Project teams to identify improvements to be introduced for future commercialization projects and monitor completion of actions from AAR
• Oversight of post-PPQ manufacturing leading to sustained supply.

The incumbent shall have in-depth understanding of the Third Party’s capabilities and capacity utilization, and to be actively engaged in their operations to ensure reliability of our Company's supply chain and to ensure 100% compliance in quality and in environment, health and safety. The incumbent shall be customer focused and have knowledge of the end-to-end supply chain for assigned products as well as the end to end product launch milestones. Education Minimum Requirement:

• Bachelor’s degree minimum in Chemical Engineering or Chemistry preferred
• Minimum 10 years experience in API manufacturing (Operations and/or technology).

Preferred Experiences:

• Depth of Manufacturing Knowledge – Has proven skills and expertise in the manufacture of Active Pharmaceutical Ingredients.
• Project Management with experience in managing a complex portfolio of projects and in particular new product introductions/technical transfers.
• Compliance – Has experience and ability to achieve compliance goals, through a risk based approach; Has a deep understanding of GMP and EHS compliance and compliance risk in API manufacturing
• Operational Excellence – Lean Six Sigma
• Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
• Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment.
• Ability to work in ambiguous situations, formulate a plan, focus on what matters, drive outcomes, and speak up and be open-minded.
• Ability to prioritize conflicting demands, act with urgency, when necessary, effective follow-ups on tasks and activities.
• Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.

Enterprise Leadership Skills:

• Networking & Partnerships - Building partnerships; developing and leveraging relationships within and across internal and external teams
• Collaborative nature, with the ability to work with diverse personalities and collaborate effectively with various functions and stakeholders.
• Influence - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
• Effective problem-solving and analytical skills, successfully navigating matrixed organizations, building consensus and influencing/driving decision-making.
• Strong communication skills to effectively engage across all levels of the business.
• Strategic Planning - Prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.

Required Skills: Accountability, Adaptability, API Manufacturing, Contract Management, Cross-Cultural Awareness, Cultural Awareness, Decision Making, Interpersonal Relationships, Inventory Management, Leadership, Manufacturing, Operational Strategies, Process Improvements, Production Scheduling, Regulatory Compliance, Risk Based Approach, Safety Management, Vendor Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 03/10/2026

• A job posting is effective until 11:59:59PM on the day BEFOREÂ the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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