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External Manufacturing Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
East Greenbush, New York
Start date
May 24, 2024

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Job Details

We are currently looking to fill a Specialist position within the New Modalities External Manufacturing (DS/FDS/API) team, specializing in viral vector manufacturing. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role oversees all aspects of contract manufacturing organizations and partners including day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance.

As a Specialist of External Manufacturing (DS/FDS/API), a typical day might include the following:

  • Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities.
  • Coordination of external manufacturing activities at contract and/or business partner sites, including but not limited to scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise.
  • Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
  • Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
  • Supporting investigations which concern external manufacturing and associated shipping operations, as required.
  • Supporting and informing strategic initiatives and contract negotiations that drive long-term relationship stability and success.
  • Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners.
  • Performing reviews of pre-production master batch records and executed batch records.

This role might be for you if:

  • You have experience in any of the following areas (recommended): GMP manufacturing experience, or viral vector manufacturing.
  • You have knowledge of bulk manufacturing techniques (recommended) cell culture, downstream purification, and/or formulation.
  • You have basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
  • You lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.
  • You have strong interpersonal, written, and oral communication skills.
  • You exhibit a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
  • You can gain understanding from provided instructions and work towards goals with minimal supervision
  • Can travel to contract manufacturers or business partners, as required (up to 25%).
  • Are comfortable with leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
  • Shows resiliency and flexibility in the face of challenge and adverse situations

To be considered for the Specialist of External Manufacturing, a BS/BA in business or scientific discipline and 2 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.

To be considered for the Associate Specialist of External Manufacturing, a BS/BA in business or scientific discipline is required.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.

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)

$58,480.40 - $106,300.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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