Executive Director, Biologics Technical Operations

Merck

3d•Onsite

About The Position

Executive Director — Biologics MS&T (m/f/d) This position is based onsite in Hyderabad, India for a duration of 2 or more years. Are you ready to lead a team at the forefront of biologics innovation? Our company is seeking an Executive Director, Head of Biologics Technical Operations where you will play a key role in advancing our biologics pipeline. In this prominent role, you will lead a Manufacturing Science & Technology team responsible for the overall technical oversight of 15kl Drug Substance facilities and DP biologics manufacturing facilities located in Hyderabad, India, responsible for managing an extensive biologics technical portfolio, and supporting routine commercial production. This role will report to Vice President (VP), Biologics S&T, and have close relationships with the Plant Manager responsible for the biologics facilities. This team will be responsible for delivering oversight and hands-on support to ensure robust, compliant, and sustainable manufacturing and packaging across the product lifecycle, supporting new product introduction through commercial scale-up, tech transfer, process validation, technical investigations, and sustained commercial manufacturing.

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.
Biopharmaceutical Operations
Change Agility
Chemical Engineering Fundamentals
Chemical Plant Operations
Consulting
Financial Acumen
Leadership Development Training
Manufacturing Scale-Up
Organizational Design
People Analytics
People Leadership
Project Controls Management
Strategic Thinking
Technical Communication

Nice To Haves

Experience in US/EU based biologics manufacturing; familiarity with work culture in India/Asia is a major advantage.

Responsibilities

Technical Ownership & Process Stewardship
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.
Process equipment SMEs for the sites they are accountable for, connected to the network of other tech ops teams with similar equipment and/or processes.
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.
Partner in support of site Run the Business activities, including risk management, deviations, audits, etc.
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.
Support execution on digital roadmap at sites
Investigations, RCA & Complex Problem Solving
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.
Capable of lab experimentation (front runs, investigational runs) for processes at site (e.g., development of reprocesses and reworks, supply investigation support); lab/scale-down capabilities most suited for drug-substance processes /analytical investigations; limited DP scale-down models.
Feed understanding and learnings from supply production into development teams and across Operations teams.
Risk Management, Monitoring & Preventive Action
Establish and support Proactive Process Monitoring at sites pre-PPQ and carry through lifecycle of product, including cross-site monitoring
Proactively monitor, maintain, and/or improve performance of commercial drug substance, drug product, packaging/assembly at site and network levels.
Detect trends at site & cross-site, as well as cross programs as appropriate, sustain and/or improve performance, including leadership of technical risk reviews to drive timely mitigations.
Support/own stewardship of product/process and unit‑operation knowledge management.
Change Control, Validation, QMS and Inspection Readiness support.
Own the change control strategy and execution for technical changes, including multi‑site change notifications and technical assessments.
Knowledge of Quality Management Systems (QMS) with proven ability to provide rapid, authoritative technical responses and evidence packages for regulatory inspections and internal audits; ensure data integrity, traceability, and defensibility.
Support/drive QMS processes: APR/CPV, cleaning/process validation, deviations, audits/inspections, regulatory submissions.
Technical Excellence and Promote Innovation (leadership responsibility)
Ensure right level of at-site technical competencies and succession plan for competencies critical to the site and across the network, avoiding duplication
Support adoption of business process improvement efforts by providing view of “how work is done” and helping to identify opportunities to streamline while ensuring compliance.
Collaborate with academia, industry and associated vendors to drive development and early adoption of novel process technologies in India