Regeneron is currently looking for an Associate Manager for our Drug Product Process Sciences team (DPPS). In this role you will build a team of Drug Product (DP) process engineers and associates in developing control strategies and systems information management and summary documentation for early and late-stage molecules. This role is critical to IOPS in defining DP processes that can be implemented at CMOs, partner sites, and internally to enable clinical supply, be validated for regulatory approval and commercial supply, and be maintained throughout a product’s lifecycle.
As an Associate Manger DPPS , a typical day might include the following:
- Drug product manufacturing process unit operations, assessment of sources of process variability, and setting of processing targets and limits
- Business tools used guide planning, technology transfer, program controls, reporting, and process validation readiness, and organization of cross functional teams to maintain information flow within these tools
- Development and maintenance of REGN internal tech transfer and process readiness procedures, including knowledge of process, facility, and adjacent stakeholder needs
- Supplying information to regulatory filings and responding to regulatory agency information inquiries, regulatory inspection support
- Aligning DP manufacturing approaches and control systems with partner companies having shared program development relationships
- Familiarity with change management systems and required decisions
- Supervision of internal personnel to effect department-specific and common IOPS goals as defined by leadership
This role might be for you if you:
- Enjoy creating reports given various types of product and manufacturing capability data, with a focus on the meaning of the data and its immediate application to drug product manufacturing processes
- Can create ways to streamline data input into reports
- Want to Support data integrity verification from original sources to translation in reports
- Want to support a consolidation effort to make sets of related reports lean
To be considered for the Associate Manager DPPS you must have a BS/BA in a scientific, engineering or related field and 6+ years of related experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$86,900.00 - $141,900.00