Regeneron is currently looking for a Sr. Manufacturing Sciences & Technology (MSAT) Specialist to join our Process Sciences Drug Product Engineering department. This role will provide key technical support for internal and external technology transfer of drug substance manufacturing processes for small molecules, oligonucleotides, peptides, and antibody conjugates.

As a Sr. MSAT Specialist a typical day might include the following:

Leads assessments of manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generates facility fit assessments and high-level gap assessments
Coordinate the creation, management, and maintenance during the lifecycle of a transfer
Accountable for generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments etc.)
Leads projects and initiatives associated with improving technical support tools for technology transfers
Collaborates with managers to continuously assess and adjust technical support activities and functions
Performs sophisticated, in-depth reviews of technical document content, including FMEAs, PAR reports, regulatory submissions, etc
Leads study teams and investigations during transfers, as applicable
Generates options to resolve technical challenges and present them for endorsement
As a person in plant, provides technical support and training of manufacturing personnel to improve understanding of synthesis, purification, and other related operations across the sites
Captures, trends, and analyzes process generated data; summarizes findings in memos, reports, and presentations
Performs review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.)
Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identifies continuous improvement activities to improve performance

This role might be for you if you:

Work optimally and efficiently in a team-oriented environment to ensure maximum and high-quality output
Have experience interacting with Contract Manufacturing Organizations
You continuously seek to improve processes for improved performance
Are willing to travel 10-15% annually
Can serve as a mentor for lower-level specialists

To be considered for the Sr. MSAT Specialist, you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences or Engineering; PhD is preferred and 5+ years of relevant experience. Experience with small molecule, oligonucleotide, peptide manufacturing process development, or process engineering experience is preferred. 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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)

$78,700.00 - $128,700.00

Sr. MSAT Specialist

Regeneron

Job Description

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Job Details