Sr Manager MSAT- Assembly, Pack & Label

Role Summary

Sr Manager MSAT- Assembly, Pack & Label at Regeneron leads a team responsible for the technical transfer and manufacturing support of robust drug product processes to support external and internal manufacturing operations globally. The role covers assembly, labeling and packaging, industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, with hands-on problem solving during technology transfer and cGMP start-up. The position serves as a process expert in equipment selection and qualification activities, ensuring site-to-site consistency after transfers and providing floor support as needed.

Responsibilities

• Develops organizational standards and systems for processes to meet growing product portfolio.
• Leads an engineering and scientific team to transfer and maintain assembly, pack, and label processes for biopharmaceutical drug products.
• Establishes standard procedures for process transfer activities and integrates those with other Regeneron business and quality systems.
• Leads all aspects of activities in assigned area of expertise, including device assembly, product labeling and packaging, incoming inspection of components, and characterizing process parameters.
• Partners with cross-functional internal and external teams to ensure successful process transfers.
• Reviews and/or approves manufacturing documentation associated with transferred processes.
• Provides on-site support during establishment of new or modified production processes, reviews process data to ensure robustness and consistency.
• Manages investigations to identify root causes and implement effective corrective and preventive actions.
• Authors or reviews technical reports and protocols in support of cGMP activities.
• Tracks and reports project achievements.
• Establishes internal and external networks to stay abreast of regulatory environment and industry standards.
• Collaborates with internal and external teams to improve process performance and cGMP operations.
• Supports innovative perspectives and encourages development of novel ideas.
• Leads, coaches, and develops direct reports; maintains required training status on Regeneron instructions and SOPs.
• Travels to contract manufacturers or business partners as required (approximately 25-50%).

Qualifications

• Required: BS/BA in a scientific, engineering, or related field; 8+ years of related experience in a pharmaceutical/biologics cGMP environment or equivalent; previous leadership experience; ability to work Monday–Friday, 8:00 a.m.–4:30 p.m.; willingness to travel.
• Required: Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g., FDA, EMA, MHRA).
• Preferred: Experience interacting with Contract Manufacturing Organizations (CMOs).
• Preferred: Technical expertise in drug product manufacturing and/or product development and validation; strong project management, interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.

Education

• BS/BA in a scientific, engineering, or related field (required).
• 8+ years of relevant pharmaceutical/biologics cGMP experience (required).

Additional Requirements

• Travel approximately 25-50% as required.