Change Control Specialist

Regeneron Pharmaceuticals, Inc.; New York (NY); Presencial; USD 62.000 - 129.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. is seeking Change Control Specialists to develop strategic plans for change control and CAPA implementation to support manufacturing operations under cGMP standards.

Roles include coordinating documentation, leading cross-functional meetings, mentoring teams, and presenting changes to senior leadership across manufacturing domains. On-site roles span Bulk Drug Substance, Technical Operations, and Fill/Finish Manufacturing.

Qualificações

• BS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience.
• 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

Responsabilidades

• Craft business plans to 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 defines scope, impact, risk, and regulatory considerations
• 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 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

Conhecimentos

Change control

CAPA

cGMP

Regulatory compliance

Formação

BS/BA in Life Sciences, Engineering, or related field

Descrição da vaga

Team: Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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

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

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $128,700.00

Similar roles

Quality Compliance Specialist, Change Control

• Team: Industrial Operations & Product Supply
• Location: East Greenbush, United States of America

Quality Control Operations Specialist

• Team: Industrial Operations & Product Supply
• Location: Saratoga Springs, United States of America

Project Specialist Quality Control

• Team: Industrial Operations & Product Supply
• Location: Rensselaer, United States of America

What people ask before they join

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Showing slide 1 of 4 (group 1 of 2)

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Be part of what’s next in science

Hear about new opportunities and stories across our teams.