Regeneron Pharmaceuticals, Inc

Senior Drug Product MSAT Engineer

Regeneron Pharmaceuticals, Inc • $78K — $128K *
Rensselaer, IN 47978In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • BS in Engineering (chemical or biomedical engineering preferred)
  • 5+ years of relevant industry experience
  • Strong background in biopharmaceutical production processes
  • Proficient in cGMP compliance and regulatory requirements
  • Experience with technology transfer and process validation activities

Responsibilities

  • Provide drug product manufacturing process expertise for new product introduction and technology transfer
  • Act as technical lead for cross-functional teams during process transfers
  • Track project milestones for equipment readiness and manufacturing documentation
  • Review and approve cGMP batch documentation essential for production
  • Assist in investigations and root cause determination for manufacturing deviations
  • Trend process performance and collaborate on process improvement initiatives
  • Author technical reports/protocols to support cGMP activities

Benefits

  • Opportunity to work in a fast-growing, science-driven organization
  • Impactful role making a difference in patients' lives
  • Collaborative work environment with multi-functional teams
  • Potential for travel and hands-on experience at various manufacturing sites
Full Job Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a Senior Drug Product (DP) Manufacturing Sciences and Technology (MSAT) Specialist to join our Process Science Drug Product Engineering department. The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities, and will be responsible for solving issues during technology transfer and cGMP start-up for internal or external manufacturing sites. They also provide on the floor support during operations, as needed, for internal or external manufacturing, reviews process data to ensure operational consistency, and provides support for investigations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

  • Location: Rensselaer, New York, United States
  • Monday-Friday, 8am-4:30pm
  • 25-50% travel domestic & occasionally internal

Discover your role:

  • Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products
  • With the support of multi-functional teams, acting as the technical lead, for technology transfer of the drug product manufacturing processes to manufacturing facilities
  • Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
  • Reviewing and approving cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities
  • Assisting with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations
  • Trending process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy
  • Authoring technical reports/protocols in support of cGMP activities
  • Supporting development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
  • Assisting in equipment selection, qualification, and start up activities and working with manufacturing to ensure robust procedures are used for operation of equipment
  • Partnering with strategic sourcing/procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
  • Supporting the drafting of regulatory filings and responding to regulatory information requests

This role requires:

  • BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience


Salary Range (annually)

$78,700.00 - $128,700.00

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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