Sr Manager MSAT (Drug Product Filling)

Summary: The Drug Product Manufacturing Science and Technology (DP-MSAT) Manager will serve as a process expert in equipment selection, CMO selection strategy, management of equipment qualification, and will be hands-on during technology transfer and cGMP start-up activities. The Manufacturing Science and Technology team will strive to establish best practices for technical support and product lifecycle management of cGMP manufacturing operations. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. The Manager and/or team will also provide floor support during operations at internal/external manufacturing facilities, use advanced analytics to review process data to ensure operational consistency and provide support for investigations.

Level to be determined based on qualifications relevant to the role

Essential Duties and Responsibilities include, but are not limited to, the following:
• Serve as a technical expert for drug product manufacturing process and new product introduction, technology transfer (to/from CMO, partner, internal sites, etc.), technical process troubleshooting and issue resolution within a GMP environment.
• Lead an aseptic manufacturing technical support team with expertise in drug product formulation, single-use system mixing, filtration, filling (i.e. vial, pre filled syringe, cartridge, etc.), lyophilization, container closure integrity, visual inspection, etc.
• Lead team for selection, installation and qualification (FAT/SAT/IQ/OQ) of cGMP manufacturing equipment. Collaborate with Manufacturing, Engineering and Quality to ensure robust procedures are developed/utilized for equipment operation.
• Accountable for global product stewardship across multiple sites.
• Track and report project milestones related to raw material/component sourcing, equipment readiness, analytical method transfer, document creation, etc.
• Review and approve cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at internal/external manufacturing facilities.
• Lead complex investigations, determine root cause, and identify/implement CAPA for manufacturing deviations.
• Trend process performance to establish/improve process capability, use advanced data analytics to ensure process is operating within intended process control strategy.
• Author policies, technical reports/protocols, change contols, etc. in support of cGMP activities.
• Support development of sampling plans for GMP batches related to lot release, stability, and characterization.
• Lead cross-functional internal and external teams to ensure successful process transfer including completion of process flow diagrams, risk assessments, FMEAs, engineering trials, process control strategies, validation, etc.
• Collaborate with internal/external teams to improve process performance and operations.
• Collaborate with Strategic Sourcing project teams to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery.
• Travel to contract manufacturers, business partners, suppliers, etc. as required. Domestic/international travel of approximately 10-40% may be necessary.
• Embrace a 'Quality-First' mindset, along with demonstrating accountability, respect, integrity, trust, teamwork and transparency, to uphold company reputation/expectations during all internal and external interactions.
• Responsible for leading, coaching, and developing direct reports as assigned.
• Maintain required training on Regeneron specific work instructions and SOP's.

Knowledge, Skills and Abilities:
• Experience interacting and technically supporting Contract Manufacturing Organizations.
• Demonstrated advanced technical expertise in aseptic drug product clinical/commercial manufacturing, product development, technology transfer, validation, product lifecycle management and applicable unit operations.
• Preferred experience with new GMP manufacturing facility design, start-up and qualification using extensive automation and electronic systems.
• Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.) including audit participation.
• Strong project management, interpersonal, cross- cultural, communication, negotiation and problem solving skills.

Education and Experience:
• Manager - BS in a scientific/engineering discipline, or related field, with 7+ years of related experience in a pharmaceutical / biologics cGMP environment.
• Sr Manager - BS in a scientific/engineering discipline, or related field, with 8+ years of related experience in a pharmaceutical / biologics cGMP environment.
• Equivalent combination of education and experience may be considered.

Level to be determined based on qualifications relevant to the role

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.