Regeneron Pharmaceuticals, Inc

Change Control Specialist

Regeneron Pharmaceuticals, Inc$62K — $128K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field, or equivalent experience
  • 0-2 years for Associate Specialist, 2+ years for Specialist, 5+ years for Senior Specialist
  • Proficiency in change control and Corrective and Preventative Actions (CAPA)
  • Strong understanding of cGMP standards
  • Ability to coordinate and lead cross-functional teams

Responsibilities

  • Develop strategic plans for change control initiatives
  • Evaluate proposed change controls against company standards
  • Prepare comprehensive change control documentation
  • Review and revise documents in compliance with cGMP
  • Conduct meetings to drive change implementation
  • Mentor teams on GMP compliant change controls
  • Monitor and manage multiple projects with timely reporting

Benefits

  • Monday-Friday work schedule
  • Standard day hours from 8am to 4:30pm
  • Opportunities for career progression within specialized departments
  • Mentorship opportunities in a collaborative environment
  • Comprehensive training programs for new employees
Full Job Description

We are seeking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.

Current Departments with Openings:

  • Bulk Drug Substance Manufacturing

  • Technical Operations

  • Fill/Finish Manufacturing

When & where:

  • Location: Rensselaer, New York, United States

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

Discover your role:

  • Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations

  • Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards

  • Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change

  • Review, edit, and revise controlled documentation in accordance with cGMP standards

  • Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation

  • Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls

  • Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner

  • Present business critical and regulatory impactful change controls to senior leadership

  • Document all training

  • Assist with the training of new employees

This role requires:

  • BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience, and the following amount of experience for each level:

    • Associate Change Control Specialist: 0-2+ years of relevant experience

    • Change Control Specialist: 2+ years of relevant experience

    • Senior Change Control Specialist: 5+ years of relevant experience

    • Level will be determined based on experience

Salary Range (annually)

$62,355.00 - $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
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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