Investigation Specialist
Regeneron Pharmaceuticals
Summary
Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases. We're seeking Investigation Specialists to join our deviation investigation teams. These positions perform all compliance related tasks vital to completing investigations and implementation of robust corrective actions for supporting manufacturing operations.
Job description
Build our future together
Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases. We're seeking Investigation Specialists to join our deviation investigation teams. These positions perform all compliance related tasks vital to completing investigations and implementation of robust corrective actions for supporting manufacturing operations.
Current Departments with Openings
- Technical Operations
- Quality Control
What you'll do
- Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
- Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
- Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
- Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
- Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
- Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
- Participating in and/or leading cross-functional study teams to get results, support and or author investigations
- Gathering, trending, and analyzing process related data to drive consistency and timeliness
Let's find out if we're a fit
- Requires B.S in life sciences, engineering or related field, may substitute proven experience for education requirement
- Associate Investigation Specialist: 0-2+ years of experience
- Investigation Specialist: 2+ years of experience
- Senior Investigation Specialist: 5+ years of experience
- Level will be determined based on experience
Requirements
- B.S in life sciences, engineering or related field
- May substitute proven experience for education requirement
- 2+ years of related experience for Investigation Specialist level
- 0-2+ years of experience for Associate Investigation Specialist level
- 5+ years of experience for Senior Investigation Specialist level
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.