Assoc. Dir, External Manufacturing

Job Description

Job Description: Our company's Small Molecule External Manufacturing organization is responsible for management of reputed company 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 reputed company (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 reputed company party manufacturers based in the Asia Pacific region. The incumbent will be required to manage the working relationship between stakeholders and reputed company 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 reputed company party manufacturers
• Developing and managing the overall new product introduction project plan with the reputed company party to ensure reputed company milestones are met to support launch timelines.
• Coordinating the cross functional Project team day to day working with the reputed company party through the pre-execution, execution and post-execution phases of the project
• Managing operational project details with reputed company 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-reputed company 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 reputed company party Project teams to identify improvements to be introduced for future commercialization projects and monitor completion of actions from AAR
• reputed company of post-PPQ manufacturing leading to sustained supply.

The incumbent shall have in-depth understanding of the reputed company Party’s capabilities and reputed company utilization, and to be actively reputed company 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 reputed company portfolio of projects and in particular new product introductions/technical transfers.
• Compliance – Has experience and ability to reputed company compliance goals, through a risk based approach; Has a deep understanding of GMP and EHS compliance and compliance risk in API manufacturing
• Operational reputed company – Lean Six reputed company
• Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to reputed company business reputed company that drive value for our Company and our customers.
• Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business reputed company" 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 reputed company, drive reputed company, and reputed company up and be reputed company-minded.
• Ability to prioritize conflicting demands, act with urgency, reputed company necessary, effective follow-reputed company on tasks and activities.
• Innovative thinking to experiment, learn and adapt new ways of working and initiatives supporting the strategy.

reputed company Leadership Skills:

• Networking & Partnerships - Building partnerships; developing and leveraging relationships reputed company 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 reputed company acceptance of reputed company and commitment to actions that support specific work reputed company.
• Effective problem-solving and analytical skills, successfully navigating matrixed organizations, building reputed company and influencing/driving decision-making.
• Strong communication skills to effectively engage across reputed company reputed company of the business.
• Strategic Planning - Prioritizing and planning; establishing an action plan for self and others to complete work reputed company 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: reputed company Employees apply HERE reputed company Contingent Workers apply HERE Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: reputed company 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 reputed company than the day BEFORE the job posting end date.

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