Role Purpose
To assess manufacturing capabilities, support the transfer of injectable filling processes, and serve as the company’s on-site technical representative at contract manufacturing facilities. The role involves overseeing process execution, identifying technical issues, and coordinating their resolution with manufacturing and quality teams.

Key Responsibilities
• Assess the technical capabilities of partner facilities’ injectable manufacturing lines and perform gap assessments against product requirements and the technology provider’s requirements.
• Review manufacturing operations from bulk receipt and preparation through filling, stoppering, closure, and relevant inspection and packaging activities, according to the product and project scope.
• Contribute to the preparation and review of technical sections of technology transfer protocols, manufacturing instructions, and batch records.
• Attend contract manufacturing sites during engineering, validation, and commercial batches to provide technical oversight of critical manufacturing activities.
• Assess line readiness before manufacturing, including equipment, primary packaging components, documentation, and personnel training.
• Monitor process parameters and in-process controls, including fill volume, stopper position, bulk storage conditions, and process hold times, against approved documentation.
• Identify and report technical issues, process deviations, and product quality risks; contribute to root cause investigations and follow up on corrective and preventive actions.
• Collaborate with the receiving site’s Manufacturing, Engineering, Quality Assurance, and Quality Control teams and the technology provider’s technical experts.
• Provide technical input into the planning and review of aseptic process simulations (media fills), process validation, and container closure integrity assessments within the assigned scope.
• Prepare technical reports on site readiness, manufacturing execution, process issues, production losses, and required actions.
 
Qualifications and Experience
• Bachelor’s degree or higher in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or a related discipline. A pharmacy degree is not mandatory.
• At least five years of relevant experience in sterile injectable manufacturing, including direct, hands-on experience in aseptic filling.
• Practical production-floor experience and the ability to identify, analyze, and follow up on manufacturing process issues.
• Strong knowledge of GMP principles applicable to sterile manufacturing, aseptic practices, and contamination control.
• Ability to review technical documentation in English and communicate effectively with international technical teams.
• Willingness to travel to contract manufacturing sites and attend production activities according to manufacturing schedules, including shift work when required.

Required Technical Competencies
• Knowledge of injectable filling equipment and stoppering and closure operations.
• Understanding of cleanroom practices and aseptic barrier technologies, including Restricted Access Barrier Systems (RABS) and isolators.
• Familiarity with environmental monitoring, aseptic interventions, and aseptic process simulations (media fills).
• Ability to review batch documentation, in-process controls, and critical process parameters.
• Familiarity with technology transfer, process validation, Process Performance Qualification (PPQ), deviation management, CAPA, and change control.
• Strong technical problem-solving, documentation, reporting, and action follow-up skills.

Preferred Experience
• Experience in filling biologics or vaccines.
• Experience with prefilled syringes (PFS) and ready-to-fill systems, including nested syringes.
• Experience in technology transfer, new product introduction, or collaboration with contract manufacturing organizations.
• Understanding of biologic product sensitivities during bulk storage, transfer, and filling, including temperature, hold times, foaming, and mechanical stress.
• Experience in analyzing production losses and improving process performance while maintaining product quality.

Personal Competencies
Attention to detail, accountability, problem-solving, evidence-based decision-making, professional collaboration with site teams, and the ability to communicate risks clearly and follow actions through to completion.