Manager, MSAT Process Lead
Role overview
After an onboarding period in Visp, Switzerland, the position will be based in the U.S. (East or Mid-West Coast) to support the expansion of small molecules/bioconjugation capabilities. Relocation targeted in Q1 2027 and assistance is available for eligible candidates and their families, if needed.
- As the MSAT Process Lead, you will define and drive process technology strategy for a new pharmaceutical manufacturing facility. - You will play a key role in facility design, technology selection, and startup, ensuring scalable, efficient, and GMP-compliant manufacturing processes. - Define and support process technology strategy aligned with product and facility needs - Lead selection and implementation of process equipment and process analytical technology (PAT) - Collaborate with internal teams and customers to understand product requirements, including critical quality attributes (CQAs), process parameters, and scale-up considerations - Develop production models (throughput, cycle times, capacity) to support facility design and operational planning - Evaluate and recommend technology solutions, balancing performance, cost, flexibility, and compliance - Provide technical input into user requirement specifications (URS), process flow diagrams, and equipment layouts - Partner with automation and OT teams to integrate process control and PAT strategies - Support commissioning and qualification activities, including FAT and SAT - Interface with stakeholders throughout design, construction, and startup phases
- 8+ years of experience in MSAT, process engineering, or technical operations within a GMP-regulated pharmaceutical or biotech environment - Bachelor’s degree in chemical engineering, Bioprocess Engineering, or related field required; advanced degree preferred - Strong expertise in process equipment, PAT, and manufacturing technologies - Experience in bioconjugates and/or advanced synthesis (e.g., complex biologics, ADCs, or small molecule processes) - Proven ability to translate product requirements into scalable manufacturing solutions - Experience supporting facility startup, commissioning, and tech transfer - Strong analytical and problem-solving skills, including production modeling and process evaluation - Familiarity with automation systems, process control strategies, and data integrity principles - Excellent communication and stakeholder management skills, including customer-facing experience - Collaborative mindset with the ability to work across functions and influence decision-making - Travel: Willingness and ability to travel to EMEA and NA at approximately 20% of the time to meet business objectives
Description
After an onboarding period in Visp, Switzerland, the position will be based in the U.S. (East or Mid-West Coast) to support the expansion of small molecules/bioconjugation capabilities. Relocation targeted in Q1 2027 and assistance is available for eligible candidates and their families, if needed.
- As the MSAT Process Lead, you will define and drive process technology strategy for a new pharmaceutical manufacturing facility. - You will play a key role in facility design, technology selection, and startup, ensuring scalable, efficient, and GMP-compliant manufacturing processes. - Define and support process technology strategy aligned with product and facility needs - Lead selection and implementation of process equipment and process analytical technology (PAT) - Collaborate with internal teams and customers to understand product requirements, including critical quality attributes (CQAs), process parameters, and scale-up considerations - Develop production models (throughput, cycle times, capacity) to support facility design and operational planning - Evaluate and recommend technology solutions, balancing performance, cost, flexibility, and compliance - Provide technical input into user requirement specifications (URS), process flow diagrams, and equipment layouts - Partner with automation and OT teams to integrate process control and PAT strategies - Support commissioning and qualification activities, including FAT and SAT - Interface with stakeholders throughout design, construction, and startup phases
- 8+ years of experience in MSAT, process engineering, or technical operations within a GMP-regulated pharmaceutical or biotech environment - Bachelor’s degree in chemical engineering, Bioprocess Engineering, or related field required; advanced degree preferred - Strong expertise in process equipment, PAT, and manufacturing technologies - Experience in bioconjugates and/or advanced synthesis (e.g., complex biologics, ADCs, or small molecule processes) - Proven ability to translate product requirements into scalable manufacturing solutions - Experience supporting facility startup, commissioning, and tech transfer - Strong analytical and problem-solving skills, including production modeling and process evaluation - Familiarity with automation systems, process control strategies, and data integrity principles - Excellent communication and stakeholder management skills, including customer-facing experience - Collaborative mindset with the ability to work across functions and influence decision-making - Travel: Willingness and ability to travel to EMEA and NA at approximately 20% of the time to meet business objectives
