Role Objective
A key objective of this role is to lead end-to-end site operations for a sterile manufacturing facility. The role is responsible for driving operational excellence across Quality, Delivery, Cost and Continuous Improvement, while ensuring strong regulatory compliance and building a high-performance manufacturing culture.
This position plays a critical role in strengthening operational readiness, supporting business growth, and ensuring consistent delivery in a regulated pharmaceutical environment.
Desired Candidate Profile:
- Education: Master's degree in Science / Pharmaceutical Sciences / related discipline preferred. Advanced certifications in manufacturing, quality, and Lean/Six Sigma are advantageous.
- Experience: 1520 years of progressive experience in pharmaceutical manufacturing with strong leadership exposure, including site-level ownership.
- Mandatory Leadership Fit (Must-Have):
- Must have been a Site Lead / Plant Head / Unit Head with end-to-end accountability (manufacturing, compliance readiness, delivery, cost, people).
- Demonstrated track record of driving QDCI rigorously and improving plant performance with measurable outcomes.
- Strong understanding and execution of OTIF metrics and delivery excellence.
- Regulatory & Compliance (Must-Have):
- Strong hands-on experience in USFDA-regulated/USFDA-inspected plants, including audit preparedness and remediation/quality maturity.
- Working knowledge of cGMP and relevant global standards like MHRA, ANVISA, etc.
- Technical Domain (Must-Have):
- Proven exposure to Sterile Injectables manufacturing, with preference for Prefilled Syringes (PFS) or closely related formats.
- Financial & Business Acumen (Must-Have):
- Full grip on budgeting, costings, COGS/COGM control, and productivity/capacity utilization.
- Ability to align manufacturing performance with business and financial goals.
- Mindset & Growth Orientation:
- High ownership, a hungry to grow attitude, high energy, and strong execution bias.
Role Requirements:
- Lead and oversee end-to-end manufacturing operations for the site, ensuring alignment with business objectives.
- Drive site performance across Quality, Delivery, Cost, and Continuous Improvement (QDCI).
- Ensure robust regulatory compliance and continuous inspection readiness for global regulatory agencies.
- Own delivery performance, ensuring On-Time-In-Full (OTIF) adherence and schedule reliability.
- Lead annual operating plans, budgets, and productivity initiatives to improve cost efficiency and capacity utilization.
- Strengthen manufacturing systems to ensure right-first-time execution, effective deviation/CAPA management, and audit readiness.
- Identify operational risks and implement contingency plans to ensure business continuity.
- Drive process improvements, automation, and technology adoption, especially within sterile manufacturing operations.
- Collaborate closely with cross-functional teams including Quality, Supply Chain, Engineering, Finance, EHS, and HR.
- Lead, mentor, and develop senior manufacturing leaders and build a strong succession pipeline.
- Take charge during critical operational situations, ensuring structured problem-solving and sustainable corrective actions.
Functional Skills:
- Manufacturing Operations Management (Sterile / Injectables / PFS preferred)
- Strong QDCI execution and governance
- Strong OTIF ownership and delivery excellence
- Quality Management Systems & cGMP compliance
- USFDA audit readiness and inspection handling
- Strategic planning, capacity planning, and execution excellence
- Budgeting, Costing, COGS/COGM control, productivity improvement
- Process automation / technology adoption / Lean / CI
Behavioral Skills Required:
- Strong leadership presence with high ownership and people development orientation
- Strategic thinking + hands-on execution mind-set
- Strong analytical and problem-solving capability
- Calm, structured crisis handling under pressure
- Growth mind-set, learning agility, and high energy (hungry to grow)
Team Size to be Manage:
- Overall responsibility for manufacturing & Operations with 3 to 4 direct reportees (AGM / Sr. Manager level) and full plant workforce under the role. In turn, Position report to Vice President Operations & Projects.
Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
