Change Control Specialist

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; Full time

Job description

Build our future together: 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 in the Bulk Drug Substance Manufacturing Technical Operations and Fill/Finish Manufacturing departments.

Location & Work Model

Rensselaer, New York, United States

Work model: Monday‑Friday, 8am‑4:30pm

Responsibilities

• 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

Qualifications

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

Salary

Annual salary range $62,355 – $128,700

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include 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/.

EEO Statement

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.