MSAT Engineer- Tech Transfer

Regeneron is currently looking for a Drug Product (DP) Manufacturing Sciences & Technology (MSAT) Engineer. This position will support equipment selection, CMO selection strategy, management of equipment qualification activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. The DP MSAT Engineer will also focus on ensuring site to site consistency after the processes are successfully transferred. They will also provide floor support during operations of off-site manufacturing, review process data to ensure operational consistency and provide support for investigations.

As DP MSAT Engineer, a typical day might include the following:

• Providing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution
• With the support of multi-functional teams, acting as the technical lead for technology transfer of the processes to manufacturing facilities
• Tracking and reporting project achievements related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation
• Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications) required to support cGMP production at manufacturing facilities
• Assisting with investigation, root cause determination, and identify/implement CAPA for manufacturing deviations
• Trending process performance to establish/improve process capability to ensure process is operating within intended process control strategy
• Authoring policies, technical reports/protocols, change controls in support of cGMP activities
• Supporting development of sampling plans for GMP batches related to lot release, stability, and characterization
• Partnering with internal/external teams to ensure process transfer
• Collaborating with internal and external teams to find opportunities to improve process performance and cGMP operations
• 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

This role might be for you if you:

• Have proven technical knowledge in drug product manufacturing, product development and validation
• Have experience interacting with Contract Manufacturing Organizations
• You continuously seek to improve processes for improved performance
• Can work independently or as part of a team
• Are OK with occasional travel up to 20-30% of the time

To be considered for the DP MSAT Engineer you must be willing to work Monday-Friday, 8am-4:30pm. You must have a BS/BA Engineering; Chemical Engineering preferred. For various levels you must have the following:

• DP MSAT Engineer: 2 years of relevant experience
• Sr. Drug Product Engineer: 5 years of relevant experience

Experience in aseptic manufacturing and/or drug product technical transfer / technical support is strongly preferred. Level is determined based on qualifications relevant to the role.

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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

About the Company:
Regeneron Pharmaceuticals, Inc.

At Regeneron, we believe in the power of original thinking. Our company is built on breakthrough ideas; which is why we foster a spirit of openness, and strive to inspire from within. We are collaborative by design and driven by curiosity. Each one of us plays an active role in transforming people’s lives through our work. Regeneron’s people make us who we are, and we are truly more than a company – we’re a community.

Simply put, we’re a tight-knit group working together to change the world.

Company Size:
5,000 to 9,999 employees

Industry:
Biotechnology/Pharmaceuticals

Founded:
1988

Website:
https://www.regeneron.com/