Associate Project Manager (Quality Control)

Role Summary

Regeneron seeks an Associate Project Manager to join the QC Analytical Sciences team. The role identifies, defines, and advances clinical-phase deliverables for Analytical Sciences in advanced therapies programs, working with internal subject matter experts, external contract manufacturers, contract laboratories, and customer groups in a matrixed environment. The Associate Project Manager ensures analytical test methods and supporting quality deliverables are established to support product manufacturing.

Responsibilities

• Serves as the Analytical Sciences representative on advanced therapies CMC 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.

Qualifications

• Required: 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
• Preferred: PMP certification.

Education

• BS/BA in chemistry, biology or related field.

Skills

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