Role Purpose
To lead the identification, assessment, and selection of contract manufacturing sites; drive technical and commercial negotiations and contract execution in collaboration with relevant functions; and manage site performance from readiness and technology transfer through commercial manufacturing, with a focus on quality, capacity, cost, and delivery commitments.

Key Responsibilities
• Identify and assess suitable manufacturing partners for the company’s portfolio, particularly sterile injectable and biologic products.
• Evaluate site capabilities, manufacturing capacity, equipment, infrastructure, and operational experience, and recommend suitable manufacturing partners.
• Lead receiving-site gap assessments against product, process, and technology provider requirements, with input from Manufacturing, Engineering, and Quality specialists.
• Translate gap assessment findings into actionable site readiness plans, including responsibilities, estimated costs, and timelines.
• Lead technical and commercial negotiations and coordinate the drafting, review, finalization, and execution of manufacturing agreements with Legal, Finance, Quality Assurance, and other relevant functions.
• Clearly define the scope of services and responsibilities for materials supply, technology transfer, line readiness, validation, manufacturing, packaging, storage, and product delivery.
• Negotiate service costs, reserved capacity, production schedules, minimum batch sizes, agreed yields and losses, payment terms, and mechanisms for addressing changes and delays.
• Coordinate the development and finalization of quality agreements under Quality Assurance leadership and ensure alignment with manufacturing agreements.
• Work with the Technology Transfer Lead and Filling and QC specialists to support site readiness and resolve technical barriers before manufacturing.
• Follow up on production schedules, material and equipment readiness, allocated capacity, and site commitments for engineering, validation, and commercial batches.
• Monitor site performance against indicators such as on-time delivery, production plan adherence, yield, losses, cost, and corrective action status.
• Manage relationships with site leadership, conduct performance review meetings, and follow contractual and operational issues through to resolution.
• Identify supply and manufacturing risks, assess alternative manufacturing options, and provide management reports and recommendations.
 

Qualifications and Experience
• Bachelor’s degree or higher in Pharmacy, Chemical Engineering, Chemistry, Biotechnology, Industrial Engineering, or a related discipline, supported by relevant technical experience.
• At least seven years of relevant pharmaceutical industry experience, including at least three years in contract manufacturing, technology transfer, manufacturing management, or manufacturing partner management.
• Direct experience in the technical assessment of, or operational collaboration with, sterile injectable manufacturing sites; biologics experience is preferred.
• Demonstrated experience in technical and commercial negotiations and involvement in drafting and finalizing manufacturing agreements.
• Ability to assess manufacturing capacity, costs, operational constraints, and risks.
• Working proficiency in English for reviewing technical documentation and contracts and participating in technical discussions.
• Willingness to travel and conduct regular visits to contract manufacturing sites.

Required Technical and Business Competencies
• Knowledge of sterile injectable manufacturing processes, particularly bulk preparation and transfer, aseptic filling, stoppering, visual inspection, and packaging.
• Understanding of key injectable manufacturing equipment and infrastructure, including cleanrooms, HVAC, pharmaceutical water systems, clean steam, and RABS or isolator technologies.
• Ability to assess line suitability for a product based on container format, batch size, line speed, capacity, and process hold times.
• Ability to perform technical gap assessments and identify matters requiring specialist Engineering, Manufacturing, or Quality review.
• Familiarity with GMP principles, contamination control, technology transfer, equipment qualification, aseptic process simulations, and process validation.
• Understanding of manufacturing and quality agreement structures and the ability to define measurable commitments.
• Ability to analyze manufacturing cost structures, compare site proposals, and negotiate based on technical and commercial considerations.
• Strong risk management, supplier performance monitoring, and contractual follow-up skills.

Preferred Experience
• Experience working with biologics or vaccine manufacturing sites.
• Experience with prefilled syringe or vial manufacturing projects.
• Experience transferring products from international technology providers to local manufacturing sites.
• Experience managing several manufacturing partners simultaneously.
• A track record of closing site readiness gaps, securing manufacturing capacity, and supporting commercial production start-up.

Personal Competencies
Strong negotiation and relationship management skills, sound technical and commercial judgment,
accountability, structured follow-up, problem-solving, conflict management, and clear reporting to support management decisions.