Drug Product MSAT Engineer- Fill Finish

Regeneron is currently looking for a DP (Drug Product) MSAT (Manufacturing Science and Technology) Engineer to join our Process Science Drug Product Engineering department. This role focuses on lifecycle management & fill finish operations. They will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands-on solving issues following technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The DP MSAT Engineer also provides floor support during operations of off-site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations.

Essential Duties and Responsibilities:

• Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
• Acts as the technical lead, with the support of cross-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
• Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
• Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
• Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations.
• Trends process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations.
• Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
• Supports development of sampling plans for GMP batches related to lot release, stability and characterization.
• Assists in equipment selection, qualification and start up activities.
• Works with Manufacturing to ensure robust procedures are utilized for operation of equipment.
• Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery.
• Maintains required training status on Regeneron specific work instructions and SOPs.
• Travels to contract manufacturers or business partners, as required, up to 25%.

This role might be for you if you:

• Have experience interacting with Contract Manufacturing Organizations.
• Demonstrate technical knowledge in drug product manufacturing, product development and validation.
• Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
• Possesses strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills required.

To be considered for the DP MSAT Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm and willing to travel. You must have a BS/BA in engineering. For various levels you must have the following:

• Associate DP MSAT Engineer: 0-2 years of relevant experience
• DP MSAT Engineer: 2 years of relevant experience
• Sr. DP MSAT Engineer: 5 years of relevant experience

Previous experience working in GMP environment is required. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$62,355.00 - $128,700.00

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