Associate Project Manager (Quality Control)

Regeneron Pharmaceuticals • Rensselaer, NY

11d

About The Position

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.

Requirements

• 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.

Nice To Haves

• PMP certification is strongly preferred.

Responsibilities

• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level