Associate Director – External Manufacturing
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Job Description
Associate Director supporting drug substance manufacture within External Manufacturing Network at a leading healthcare company. Driving technical leadership and ensuring compliance in manufacturing processes through collaboration.
Responsibilities:
- Lead and act as the primary interface on technical issues between technical operations and external partner
- Provide technical leadership within technical operations group for commercialization and manufacture of drug substance
- Provides technical guidance to external partner, assesses viability of technology in proposed process configurations
- Collaborates with external manufacturing operations, external quality, regulatory, to evaluate external partner performances
- Executes technical due diligence assessments at external partner
- Ensures tech transfers are positioned for successful business outcomes
- Executes validation strategies for new and existing products
- Provides manufacturing process support to external partners to resolve production issues
- Supports/coordinates/manages complex investigations
- Drives and supports continuous process verification and process performance monitoring program
- Understands the true regulatory requirements and partners with operations, quality, to develop more efficient ways to meet these requirements.
Requirements:
- Bachelor’s degree in engineering, chemistry sciences or related discipline
- Minimum of 7 years of relevant work experience in manufacturing
- Minimum of 5 years 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
- Strong problem-solving skills, root cause analysis and risk assessment/mitigation
- Ability to work effectively across boundaries to build strong collaborative relations
- A high level of effectiveness in professional and interpersonal communication skills
- 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).
Benefits:
- Flexible Work Arrangements
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