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Regeneron is currently looking for a Sr. Manager DP (Drug Product) MSAT (Manufacturing Sciences & Technology) to join our Process Sciences Drug Product Engineering (PSDPE) team. This role leads a team responsible for the technical transfer and manufacturing support of robust drug product processes to support external and internal manufacturing operations globally. The team is responsible for supporting assembly, labeling and packaging and industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic. This role serves as a process expert in equipment selection, CMO selection strategy, management of equipment qualification activities, and will be hands-on solving issues during technology transfer and cGMP start-up. They're also responsible for ensuring site to site consistency after the processes are successfully transferred, provides floor support as necessary, reviews process data and supports investigations.

As a Sr. Manager DP MSAT, a typical day might include the following:

+ Develops organizational standards and systems for processes to meet growing product portfolio.

+ Leads an engineering and scientific team to transfer and maintain assembly, pack, and label processes for biopharmaceutical drug products.

+ Establishes standard procedures for process transfer activities and integrates those with other Regeneron business and quality systems.

+ Leads all aspects of activities in assigned area of expertise, which may include supporting activities in device assembly, product labeling and primary and/or finished packaging, incoming inspection of components, and characterizing assembly, pack, and label process parameters.

+ Partners with cross-functional internal and external teams to ensure successful process transfers.

+ Reviews and/or approves manufacturing documentation associated with transferred processes.

+ Provides on-site support during establishment of new or modified production processes, reviews process data to ensure operational robustness and consistency.

+ Manages investigations related to assigned area to identify a root cause(s) and to identify and implement effective corrective and preventive actions.

+ Authors or reviews technical reports and protocols in support of cGMP activities.

+ Tracks and reports project achievements.

+ Establishes an internal and external network to stay abreast of current regulatory environment and industry standards.

+ Collaborates with internal and external teams to seek out opportunities to improve process performance and cGMP operations.

+ Supports innovative perspectives within organization and encourages development of novel ideas.

+ Responsible for leading, coaching and developing direct reports.

+ Maintains required training status on Regeneron specific work instructions and SOPs.

+ Travels to contract manufacturers or business partners, as required, approximately 25-50%.

This role might be for you if you:

+ Have experience interacting with Contract Manufacturing Organizations.

+ Demonstrate technical expertise in drug product manufacturing and/or 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.

To be considered for the Sr. Manager DP MSAT you must be able to work Monday-Friday, 8am-4:30pm and willing to travel. You must have a BS/BA in a scientific, engineering or related field and 8+ years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience. Previous leadership experience 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 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)

$126,300.00 - $206,100.00