Executive Director, Biologics Technical Operations
MSD
full-time
Posted on:
Location Type: Office
Location: Hyderabad • India
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Job Level
About the role
- Lead receiving unit New Product Introduction & Tech Transfer activities, ensuring deep understanding of the interconnectivity between operations and the science behind our products (e.g., end-to end risks, control strategy) to drive on-time and right-first time process and site introduction and to influence/guide development and characterization.
- Maintain on site presence, providing on-site SME support during PPQ, early production and transfer to new nodes and throughout commercial manufacture of the product; act as escalation point for multi‑site issues.
- Oversight for creation and maintenance of critical site-based documentation (first time generation especially) leading up to production batches – batch records, recipes, sampling plans, etc.
- Support Response to questions from regulatory authorities that affect site activities, working with site CMC on ongoing regulatory support for changes and submissions.
- Support product life cycle management – developing and implementing process changes to ensure long term product robustness and compliance and driving productivity through day-to-day application of Six Sigma principles.
- Lead complex/significant investigations (deviations, OOS/OOT, contamination/impurity events), ensuring rigorous hypotheses and data‑driven RCA, experimentation, and identification and installation of durable improvements and/or CAPAs.
Requirements
- B.S. /M.S. /Ph.D. in relevant Engineering or Science fields.
- At least 15 years of experience in biopharmaceutical manufacturing and/or development, emphasizing science and technical roles.
- Proven technical excellence and a deep understanding of biologics molecules, manufacturing processes, and commercialization principles.
- Experience in biologics drug substance, drug product development, technical operations and new product introduction.
- Experience in US/EU based biologics manufacturing; familiarity with work culture in India/Asia is a major advantage.
- Strong skills in cross-divisional networking and collaboration, both from an influencing and direct management perspective.
- Experience with regulatory filings, quality notifications, investigations and CAPA mgmt.
- Demonstrated leadership with the ability to influence at all organizational levels.
- Strong talent-building skills, with strategic and detail-oriented capabilities.
- Solid understanding of product management systems, business and financial skills, and the ability to manage multiple programs.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biopharmaceutical manufacturingbiologics drug substance developmentbiologics drug product developmenttechnical operationsnew product introductionregulatory filingsquality notificationsinvestigationsCAPA managementSix Sigma principles
Soft Skills
cross-divisional networkingcollaborationinfluencingleadershiptalent-buildingstrategic capabilitiesdetail-oriented capabilities