Description

Regeneron is currently looking for an Associate Project Manager to join our QC (Quality Control) AS (Analytical Sciences) team. The Associate Project Manager - QC works to identify, define and progress the clinical phase project deliverables for Analytical Sciences for advanced therapies programs. Working with internal subject matter experts, external contract manufacturing organizations, external contract labs and customer groups in a matrixed team environment, the Associate Project Manager ensures that analytical test methods and supporting quality deliverables are established to support product manufacturing.

As an Associate Project Manager, a typical day might include the following:

Serves as the Analytical Sciences representative on advanced therapies CMC (Chemistry, Manufacturing and Controls) program teams, acting as the primary point of contact for analytical topics, program milestones, and risk/issue escalation.
Builds and nurtures strong partnerships with external contract laboratories, overseeing outsourced analytical programs to drive shared accountability, consistent communication, and high-quality, on-time deliverables.
Communicates cross-functionally within Analytical Sciences to align method development needs, resourcing, and timing for each clinical-phase program.
Ensures analytical activities (internal and external) adhere to appropriate phase-appropriate quality systems, data integrity principles, and regulatory expectations.
Develops a cohesive strategy for each clinical phase program and is responsible for the execution of that strategy.
Uses technical knowledge to ensure customer groups are provided with the appropriate analytical services including ensuring appropriate assays are in place for manufacturing sampling plans.
Partners with CMC Regulatory Sciences, Quality Assurance, Manufacturing, Process Sciences, and Technical Training to define analytical deliverables and supporting documentation (reports, protocols, method development plans, technical memos, forms).
Collaborates with CMC Reg Sci to support regulatory filings.
Identifies, implements, and scales tools and templates (e.g., dashboards, trackers, method development frameworks, tech transfer packages) to improve team quality and efficiency.
May own the implementation of CAPAs for Analytical Sciences and/or assist with quality events.

This role might be for you if:

You have excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company.
You can navigate a fast-paced and ambiguous environment to create a detailed program plan with defined deliverables and timelines.
Can resolve and negotiate conflicts or problems with tact, diplomacy and composure.
You have experience with MS Project, or related project management tools.

To be considered for this position you must have a BS/BA in chemistry, biology or related field with 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries. PMP certification is strongly preferred.

Level will be determined based on qualifications necessary for the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$92,200.00 - $150,600.00

Associate Project Manager (Quality Control)

Description

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