Senior Drug Product MSAT Engineer

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a Senior Drug Product (DP) Manufacturing Sciences and Technology (MSAT) Specialist to join our Process Science Drug Product Engineering department. The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities, and will be responsible for solving issues during technology transfer and cGMP start-up for internal or external manufacturing sites. They also provide on the floor support during operations, as needed, for internal or external manufacturing, reviews process data to ensure operational consistency, and provides support for investigations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Rensselaer, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel percentage: 25-50% domestic & occasionally international

Discover your role:

• Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products
• With the support of multi-functional teams, acting as the technical lead, for technology transfer of the drug product manufacturing processes to manufacturing facilities
• Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
• Reviewing and approving cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities
• Assisting with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations
• Trending process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy
• Authoring technical reports/protocols in support of cGMP activities
• Supporting development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
• Assisting in equipment selection, qualification, and start up activities and working with manufacturing to ensure robust procedures are used for operation of equipment
• Partnering with strategic sourcing/procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
• Supporting the drafting of regulatory filings and responding to regulatory information requests

This role requires:

• BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

 

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.  If you have any questions, please speak with your recruiter. 

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$67,400.00 - $128,700.00