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External Manufacturing Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Aug 11, 2022

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Job Details

The External Manufacturing Specialist coordinates all aspects of contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.

Your day to day could include, but are not limited to, the following:

  • Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites (CMO's) concerning day-to-day activities.
  • Coordinates external manufacturing activities at CMO's including: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, 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.
  • Liaises between various departments within Regeneron including, 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.
  • Supports all investigations which concern external manufacturing and associated shipping operations.
  • Ensures product integrity and company reputation by monitoring of cGMP compliance at contract manufacturers and business partners.
  • Performs reviews of pre-production master batch records and completed batch records.
  • Travels up to 25% (domestic and international), as required.
Education and Experience:
  • Specialist: Requires BS/BA in scientific subject area and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
  • Senior Specialist: Requires BS/BA in scientific subject area and 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.

Knowledge, Skills and Abilities:

  • Knowledge of external manufacturing from formulation through the final package.
  • Basic knowledge of regulatory compliance of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
  • Strong interpersonal, written and oral communication skills.
  • Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
  • Gains understanding from provided instructions and works towards goals with minimal supervision.
  • Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
  • Shows resiliency and flexibility in the face of challenges and adversarial situations.
  • Understands and listens to team members and partners needs while supporting productive team environments toward a common objective.
  • Experience in collaborating with CMOs/CROs preferred.

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.

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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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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