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

WHY PATIENTS NEED YOU

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.

WHAT YOU WILL ACHIEVE

Responsibilities include establishing reference materials, creating stability protocols, monitoring product stability, authoring stability sections of regulatory submissions, and applying phase-appropriate strategies to enroll, develop, and advance projects towards registration.

HOW YOU WILL ACHIEVE IT

• Liaise 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.

• Collaborate with cross-functional roles including the ARD, PhRD, and BRD Leads to support project enrollment and clinical development up through product registration.

• Monitor 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.

• Lead and support product-related investigations such as OOS/OOT as QC SME.

• Represent QC in technology transfer teams both internally and externally, as needed.

• Represent QC at applicable project governance meetings and other decision-making bodies.

QUALIFICATIONS

Must-Have

• Applicant must have a 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.

Nice-to-Have

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

OTHER JOB DETAILS

• Last Date to Apply for Job: July 27, 2026

• Additional Location Information:  MO - St. Louis - Chesterfield

• Eligible for Relocation Package – NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.