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We are looking to fill a Principle Manufacturing Specialist & Technology Specialist with a Mon-Friday 8:00am-4:30pm schedule. 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.

A typical day might include:

+ 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, as appropriate).

+ 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.

+ Can work independently or as part of a team.

+ Are okay with travel up to 10-15% of the time.

+ Can serve as a mentor for lower-level specialists.

To be considered for this role you must hold a BS/BA in engineering or scientific discipline and the following minimum of proven experience:

+ Principal Specialist: 8+ years

+ Staff Specialist: 10+ years

+ Small molecule, oligonucleotide, peptide manufacturing process development, or process engineering experience a plus.

May substitute proven experience for education requirement. 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 and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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)

$90,800.00 - $173,400.00