Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Acts as a site-level Manufacturing Science & Technology Expert, delivering advanced technical expertise across pharmaceutical manufacturing processes and enabling technologies throughout the product lifecycle. The role is accountable for maintaining commercial manufacturing processes in a sustained state of control while continuously enhancing process robustness, performance and compliance. As an individual contributor within MSAT, this position plays a key role in supporting complex technology transfers, scale-up activities and commercial batch readiness. Through the implementation of innovative manufacturing technologies, and the execution of targeted technical improvements, the role directly contributes to site performance, client milestone delivery by improving right-first-time execution.
KEY RESPONSIBILITIES:
• Knowledge Management
- Acts as the site owner for assigned pharmaceutical manufacturing process technologies, covering pilot activities, scale-up and scale-down operations, and experimental design approaches (DoE).
- Ensures a strong and sustainable knowledge base within the area of expertise by developing and delivering structured training and learning initiatives for Process Experts and Operations teams.
- Drives internal and external benchmarking activities, leveraging scientific, academic and industry sources to continuously expand technical know-how and disseminate best practices across the organization.
• Subject Matter Expertise for Technology Platforms
- Provides in-depth technical expertise for assigned technology platforms or pharmaceutical processes throughout the lifecycle, from process transfer and launch through routine commercial manufacturing.
- Leads and governs process optimization and continuous improvement initiatives within the scope of expertise.
- Applies advanced process characterization techniques to strengthen process robustness, sustainability and control strategies.
- Supports complex troubleshooting activities by acting as second-level technical authority, harmonizing and optimizing technical solutions across manufacturing units as needed.
• Single Point of Contact (SPoC) for Technology
- Serves as the primary technical interface with the global MSAT network, technical development functions and other sites to support global initiatives and alignment.
- Contributes to the development, deployment and continuous improvement of technical standards, manufacturing platforms and enabling technologies, including equipment and Process Analytical Technologies (PAT).
- Leads or supports technical feasibility studies, engineering trials and demonstrations related to process enhancements and introduction of new manufacturing technologies.
• Process Equipment Selection
- Provides technical input into the definition and selection of manufacturing equipment, contributing to User Requirement Specifications (URS) and ensuring alignment with process and site needs.
• Audit, Compliance & External Readiness
- Maintains all activities in a constant state of inspection readiness and provides technical support during internal and external audits.
- Reviews and contributes to regulatory and technical documentation as required.
- Participates in due diligence activities for in-licensing or strategic projects, where applicable.
• Training & Scientific Leadership
- Owns and maintains the training curriculum associated with the role and supports onboarding and capability development of new associates.
- Delivers technical training and education on assigned technologies to Process Experts, Product Stewards and Operations teams.
- Acts as a recognized technical authority by presenting scientific and technical work at internal and external forums.
QUALIFICATIONS & EXPERIENCE:
- Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Engineering field, Chemistry or a related scientific discipline; Master’s degree or equivalent experience preferred.
- Demonstrated experience in GMP pharmaceutical manufacturing environments, with strong knowledge of manufacturing processes, regulatory requirements and quality systems.
- Proven hands-on experience with Pre-Filled Syringe (PFS) manufacturing systems, including process technologies, equipment and operational aspects across the manufacturing lifecycle.
- Minimum of 8 years of relevant experience in manufacturing science, technology or process engineering roles within regulated environments.
- Ability to independently lead complex technical activities, including process characterization, optimization and technology transfer from development to commercial manufacturing.
- Fluent in English; proficiency in the local site language required.