Analytical QC Portfolio Lead (R3 - R4 Level) (Secondment - 12 Months)

Pfizer•Saint Louis, MA

3d•Hybrid

About The Position

This secondment position is considering applicants at the R3 to R4 levels. The Quality Control (QC) Portfolio Lead serves as a single point of contact representing QC on Analytical Research & Development (ARD) project sub-teams. This role is accountable for all QC deliverables to ensure project progression and will work directly on peptide and/or vaccine projects. This role requires close collaboration with Validation/Transfer SMEs, manufacturing site representatives, Quality Assurance, Regulatory Affairs, testing laboratories, and other CMC-focused business lines.

Requirements

Bachelor's degree with at least 6+ years of experience
Scientific excellence demonstrated in a Quality Control functional role
Experience representing one or more QC functions on a project team with defined objectives and endpoints
Able to manage diverse activities to deliver on milestones according to set timelines
Able to collaborate and maintain self-accountability in a matrix environment
Strong communication skills, able to present complex technical concepts to enable understanding by colleagues from all disciplines / all levels
Strong project management skills and experience managing multiple projects at the same time is essential
Strong time management skills with attention to detail and desire to achieve team and individual goals
Permanent work authorization in the United States

Nice To Haves

Master's degree with at least 4+ years of experience; OR a PhD with 0+ years of experience

Responsibilities

Establishing reference materials
Creating stability protocols
Monitoring product stability
Authoring stability sections of regulatory submissions
Applying phase-appropriate strategies to enroll, develop, and advance projects towards registration
Liaising between ARD Sub-team and the QC functions to facilitate project progression, communicating progress, challenges, and risks in a timely manner for peptide product programs
Collaborating with cross-functional roles including the ARD, PhRD, and BRD Leads to support project enrollment and clinical development up through product registration
Monitoring product stability, evaluating trends, product quality changes, and extending shelf-life (use periods) as needed
Authoring and data verifying subsections of regulatory submissions such as IND/IMPD/BLA
Authoring responses to Health Authority information requests pertaining to QC
Leading and supporting product-related investigations such as OOS/OOT as QC SME
Representing QC in technology transfer teams both internally and externally, as needed
Representing QC at applicable project governance meetings and other decision-making bodies