Regeneron Pharmaceuticals, Inc

Principal External Manufacturing Specialist (Drug Product)

Regeneron Pharmaceuticals, Inc • $78K — $150K *
Rensselaer, NY 12144In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 days ago
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Job Overview by Ladders

Qualifications

  • BS/BA in a scientific discipline
  • 5+ years of experience in cGMP manufacturing operations for Senior Specialist; 8+ years for Principal Specialist
  • Knowledge of regulatory compliance including cGMP, FDA, ICH, EU regulations
  • Proficient with Excel, PowerPoint, Visio, Word, Oracle
  • Excellent interpersonal, written, and oral communication skills
  • Ability to work independently and as part of a team
  • Creative problem-solving skills and resilience in challenging environments

Responsibilities

  • Serve as the operational contact for contract manufacturing activities
  • Coordinate external manufacturing activities, including scheduling and material supply
  • Manage multiple external manufacturing operations across various sites
  • Liaise between departments like Quality Control, Quality Assurance, and Supply Chain
  • Lead teams for continuous process improvements and strategy development
  • Support investigations regarding external manufacturing issues
  • Ensure cGMP compliance and product integrity at external sites

Benefits

  • Monday-Friday work schedule, 8am-4:30pm
  • Up to 25% travel opportunities
  • Opportunity to lead and mentor teams
  • Involvement in continuous process improvements
  • Exposure to both domestic and international operations
  • Dynamic work environment with various departmental interactions
Full Job Description

Senior/Principal External Manufacturing Specialist oversees all aspects of external manufacturing 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. Additionally, the role provides guidance to other specialists as well as consults with management on all contract manufacturing operations and GMP compliance issues.

When & where:

  • Location: East Greenbush, New York, United States

  • Work model: Monday-Friday, 8am-4:30pm

  • Travel: up to 25%

Discover your role:

  • Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.

  • Coordinates 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 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.

  • Coordinates/oversees multiple external manufacturing activities at multiple sites, as required.

  • Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.

  • Leads sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.

  • Leads or supports all investigations which concern external manufacturing and associated shipping operations.

  • Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.

  • Performs reviews of pre-production master batch records and executed batch records.

  • Authors documents and procedures.

  • Supports audit operations, both internal and external.

  • Analyzes data for trends and potential issues.

  • Travels 25% (target) or more (domestic and international), as required.

This role requires:

  • BS/BA in a scientific discipline and the following years of experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience, for each level:

    • Senior Specialist - 5+ years

    • Principal Specialist - 8+ years

    • Level will be determined based on experience

  • Knowledge of external manufacturing from formulation through the final package.

  • Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.

  • Proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.

  • Strong interpersonal, written and oral communication skills.

  • Confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.

  • Ability to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.

  • A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.

  • Resiliency and flexibility in the face of challenges and adversarial situations.

  • Understanding and listening to team members and stakeholders needs while supporting productive team environments toward a common objective.

Salary Range (annually)

$78,700.00 - $150,600.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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