Principal Manufacturing Sciences & Technology Engineer

BioSpace; Town of East Greenbush (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron is seeking a Principal MSAT Engineer to lead equipment selection, qualification, and support for drug product manufacturing during technology transfer and cGMP start-up. You will collaborate with internal and external teams to resolve issues and ensure compliant operations.

Based in East Greenbush, NY, this role requires 25-50% travel, Monday–Friday work hours, and hands-on leadership of MSAT activities across manufacturing and contract manufacturers, with a strong focus on process

Qualifications

• BS/BA in Engineering, Chemical Engineering, or Biomedical Engineering preferred.
• 8+ years of MSAT experience for Principal MSAT Engineer.
• Experience with cGMP, drug product manufacturing and technology transfer.

Responsibilities

• Serves as technical lead for drug product manufacturing process transfer and troubleshooting.
• Oversees equipment selection, qualification and start-up activities.
• Tracks milestones and collaborates with internal and external teams for successful transfer.
• Reviews batch documentation and supports cGMP compliance at contract manufacturers.
• Investigates deviations, identifies root causes and implements CAPA.
• Leverages SME knowledge to resolve issues and support regulatory compliance.

Education

BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred

Job description

Build Our Future Together

Regeneron is seeking a Principal MSAT Engineer to join our Process Sciences Drug Product Engineering department. This role supports and/or leads equipment selection, CMO selection strategy, management of equipment qualification and/or process validation activities and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of internal or external manufacturing, reviews process data to ensure operational consistency after processes are successfully transferred and provides support for investigations.

When & Where

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Travel percentage: 25-50% domestic & occasionally international

Discover Your Role

• Serves as technical lead and subject matter expert for drug product manufacturing process transfer, providing oversight for new product introduction, technology transfer, and process troubleshooting/issue resolution


• Tracks and reports project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partners with/leads cross-functional internal and external teams to ensure successful transfer execution


• Reviews and approves cGMP batch documentation (master batch records, specifications, validation protocols) and authors policies, technical reports, protocols, and change controls in support of cGMP activities


• Monitors cGMP compliance at drug product contract manufacturers to protect product integrity and company reputation


• Trends process performance to establish and improve process capability, ensuring operations remain within the intended control strategy


• Investigates deviations, determines root cause, and identifies/implements CAPA; develops sampling plans for GMP batches (lot release, stability, characterization)


• Collaborates with internal/external teams to identify and drive opportunities for improved process performance and cGMP operations


• Leads or assists in equipment selection, qualification, and start-up activities, and works with Manufacturing to ensure robust operating procedures


• Partners with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services, ensuring on-time vendor delivery


• Works with DP MSAT management to define organizational structure, prioritize strategic initiatives, and assess staffing needs to support growth


• Leverages subject matter expertise to resolve emerging issues and escalates to line management as needed to manage impact


• Bring demonstrated technical knowledge in drug product manufacturing, product development, and validation, along with experience interacting with Contract Manufacturing Organizations


• Apply strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA

This Role Requires

• BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred


• Principal MSAT Engineer: 8+ years of relevant experience


• Staff MSAT Engineer: 10+ years of relevant experience


• Level is determined based on qualifications relevant to the role

Salary Range (annually)

$92,200.00 - $150,600.00

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. For more information about onsite expectations for your role and location.