MSD Assoc Dir External Manufacturing 

India, Maharashtra, Mumbai 

418219983

Job Description

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.

• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.

• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.

• Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement

• Executes technical due diligence assessments at external partner(s).

• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.

• Executes validation strategies for new and existing products.

• Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.

• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.

• Provides a technical review of external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems.

• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.

• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer

Required Skills and Experience:

• Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing
• Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support.
• Strong problem-solving skills, root cause analysis and risk assessment/mitigation
• Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results
• A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required.
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
• Must be able to work under own initiative, prioritise appropriately based on business need and work within tight deadlines.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of quality systems, drug substance manufacturing and validation.
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position at approximately 25%

Preferred Experience and Skills:

• Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential.
• Lean Manufacturing / Six Sigma Experience
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Current Contingent Workers apply

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