Assoc. Dir, External Manufacturing

Job Description

Job Description:

Our companys Small Molecule External Manufacturing organization is responsible for management of third party manufactures of our Companys 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.

• Coordinating risk management process through the project lifecycle.

• 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 Partys capabilities and capacity utilization and to be actively engaged in their operations to ensure reliability of our Companys 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:

• Bachelors 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:

Preferred Skills:

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