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.

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.

Executive Director, Biologics Technical Operations

Key skills