Job Type
Full-time
Description
Position Summary: We are seeking a dedicated and mission-driven professional to join our team in advancing vaccine research, development, and global immunization efforts. This role supports critical initiatives aimed at improving public health outcomes through the discovery, evaluation, and delivery of safe and effective vaccines. The successful candidate will contribute to cross-functional projects involving scientific research, clinical development, regulatory compliance, nonclinical studies, and global health strategy. Working closely with internal teams and external partners, the candidate will help ensure the timely progression of vaccine programs from early-stage research through to implementation in low-, middle-, and high-income countries. This position requires strong analytical skills, scientific curiosity, and a deep commitment to equity in global health.
Key Responsibilities:The QC Program Implementation Lead will establish Sabin's first dedicated QC capability by designing and implementing a phase-appropriate, current Good Manufacturing Practice (cGMP)-compliant QC framework that supports the transition from Phase 2 through Phase 3, Process Performance Qualification (PPQ), Biologics License Application (BLA), and commercialization. Working closely with Sabin's existing Analytical Sciences and CMC Quality team and external laboratories/Contract Development and Manufacturing Organizations (CDMOs), the role will establish the QC operating model, governance, processes, technical standards, and interfaces needed to ensure reliable and compliant drug substance and drug product testing.
GMP QC Program & Governance
- Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory, and Program Management to establish and maintain appropriate governance and sponsor oversight of laboratories and CDMOs performing testing on Sabin's behalf.
- Define QC roles, decision rights, handoffs, documentation requirements, and escalation pathways within Sabin's existing program governance and applicable quality agreements.
- Support CMC Analytical Sciences to establish phase-appropriate QC strategies and standards aligned with product development, control strategy, regulatory requirements, and commercialization objectives.
- QC oversight of analytical method lifecycle management, specifications, release and stability testing, reference standards and critical reagents for release testing, contract testing laboratory oversight investigations, and inspection readiness.
Analytical & Technical QC Oversight
- Provide sponsor-level QC oversight of analytical PPQ readiness, including implementation and ongoing performance of validated in-process, release, characterization, and stability methods supporting drug substance and drug product.
- Partner with Analytical Sciences and external partners to ensure appropriate method transfer, qualification/validation, implementation, lifecycle management, and ongoing technical support.
- Provide technical leadership and risk-based decision-making for significant analytical and QC issues and their potential product or regulatory impact.
- Review QC readiness and testing documentation supporting PPQ batches, including specifications, sampling and testing requirements, reference-standard and critical-reagent availability, method status, laboratory readiness, data review, investigations, certificates of analysis, and stability commitments.
- Provide QC leadership for significant out-of-specification (OOS)/out-of-trend (OOT) results, deviations, and other QC-related quality risks, including assessment, escalation, and resolution. Identify and escalate data integrity concerns through Sabin's enterprise quality system in partnership with CMC Quality. Quality, and external testing partners, while building a practical QC capability that can scale with Sabin's development programs.
External Laboratory & CDMO Oversight
- Ensure quality agreements clearly define responsibilities for testing, data review and transfer, records retention, audit access, investigations, change notification, reference standards, sample management, stability activities, and escalation of significant events.
- Ensure external QC activities are appropriately qualified, controlled, monitored, and aligned with GMP requirements, quality agreements, data integrity expectations, and regulatory commitments.
- Oversee vendor performance, testing activities, QC documentation, investigations, changes, and escalation of significant risks or issues.
Quality, Compliance & Readiness
- Establish and maintain a fit-for-purpose QC framework, procedures, and quality systems supporting outsourced testing activities.
- Provide QC leadership for significant OOS/OOT results, deviations, data integrity concerns, and other quality risks, including assessment, escalation, and resolution.
- Support regulatory and US Government (USG) submissions, audits, and inspections by ensuring that QC data and supporting records are complete, accurate, attributable, traceable to source documentation, appropriately reviewed, and consistent across analytical reports, certificates of analysis, stability reports, regulatory submissions, and other required deliverables.
QC Leadership & Program Execution
- Serve as the QC representative on CMC and cross-functional program teams, ensuring QC requirements, dependencies, risks, and deliverables are integrated into program planning.
- Provide strategic and technical leadership across QC activities, applying risk-based decision-making to address evolving program needs and unexpected issues.
- Partner across functions and with external organizations to establish clear accountability, communication, and escalation pathways throughout Phase, PPQ, BLA, and commercialization.
QC Capability & Continuous Improvement
- Develop and evolve Sabin's outsourced QC capability, including external laboratory/CDMO relationships, technical expertise, systems, governance, and future organizational needs.
- Establish appropriate performance metrics and governance mechanisms to assess the effectiveness of the external QC network, identify risks, and drive continuous improvement.
- Perform other duties as assigned.
Requirements
- Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline; advanced degree preferred.
- 14+ years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment, including experience supporting late-stage development and/or commercial manufacturing.
- Experience supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency, is preferred.
- Experience with analytical PPQ readiness, vaccine release and stability testing, sponsor oversight of external testing laboratories, and preparing or reviewing QC data for regulatory submissions is strongly preferred.
- Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing environment is preferred.
- Demonstrated experience overseeing outsourced QC activities, analytical laboratories, CDMOs, Contract Research Organizations (CROs), or other external testing organizations within a GMP environment.
- Strong knowledge of GMP QC principles, analytical method lifecycle management, method transfer, qualification/validation, specifications, stability, and release testing, OOS/OOT investigations, data integrity, and inspection readiness; vaccine experience strongly preferred.
- Demonstrated ability to establish QC governance and oversight within a virtual or matrixed organization and effectively manage technical relationships with external partners.
- Strong risk-based decision-making, problem-solving, and communication skills, with the ability to address unexpected QC issues and clearly communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner audiences.
- Demonstrated ability to lead through ambiguity and changing program needs, with a practical, hands-on approach to establishing processes, managing external partners, and building a fit-for-purpose QC program. Experience in both development/start-up and commercial GMP environments is strongly preferred
Other: - Subject to a criminal background investigation
- Request for three professional references
- Verification of education/degrees
Work Authorization:This position is not eligible for visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.
Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation, and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $216,000 to $243,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.
Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.
Notice to Recruiters/Staffing Agencies Recruitment vendors may not contact Sabin hiring managers, executives, or employees and must have an executed agreement on file. Unsolicited resumes do not create an agreement, and Sabin is not responsible for related fees.
Salary Description
$216,000 to $243,000
