Senior Specialist, Quality Control, Bioassay Second Shift

Step into a critical leadership and analytical oversight role within a world-class Quality Control Bioassay ecosystem. Reporting directly to the QC Bioassay Manager, you will serve as the technical anchor for analytical data review, method lifecycle activities, and root-cause quality investigations supporting product release and stability. If you thrive on applying strong scientific judgment to cell and molecular biology assays, driving timely resolution of complex laboratory events, and mentoring team members in an audit-ready, 100% onsite GMP environment, this opportunity places you at the center of mission-critical biopharmaceutical operations.

Balancing data review, hands-on laboratory support, and quality system leadership, your core responsibilities will include:

Analytical Data Review & Release: Perform thorough review and approval of executed assay packages across paper and electronic formats, focusing on Molecular and Cell Biology techniques (qPCR, Sequencing, electrophoresis, cell-based ELISA, and potency assays).

Quality Systems & Investigations: Lead, author, investigate, and close out complex Quality Events within established timelines, including deviations, Out of Specification (OOS) results, CAPAs, and Change Controls.

Method Lifecycle & Transfers: Support Method Qualification, Method Acquisition, method transfers, development projects, and equipment/assay troubleshooting.

Operational Alignment & Shift Support: Provide real-time decision-making, issue escalation, and coordination across internal and external laboratories (CMOs) to ensure business continuity, capacity alignment, and cGMP compliance—particularly during evening operational hours.

Technical Documentation: Author, review, and approve SOPs, test methods, QC release documentation, Certificates of Analysis (CoA), stability data packages, instrument qualifications, and computerized system validation files.

Audit Readiness & Mentorship: Support audit preparation and official inspection responses, provide technical guidance on compliance matters, and coach junior QC analysts on testing techniques and troubleshooting.

Education: Bachelor’s Degree (BA/BS) in a scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Pharmacy, or related field). A Master’s Degree (MS) in a relevant discipline is highly valued.

Experience: Minimum of 4 years of relevant laboratory experience with a BA/BS (or 2 years with a relevant MS), focusing on Mammalian Cell and/or Molecular Biology within a regulated cGMP environment.

Technical Expertise: Solid background in molecular/cell assays such as qPCR, sequencing, and electrophoresis; hands-on familiarity with cell-based ELISA and in vitro potency assays is preferred.

Quality & Regulatory Systems: Demonstrated experience leading deviations, OOS investigations, CAPAs, and change controls. Working knowledge of FDA, EU/EMA, and ICH guidelines, Good Documentation Practices (GDP), and Data Integrity requirements.

Languages: Minimum C1 English proficiency (fluent technical writing and cross-functional verbal communication in an international matrix structure).

Work Arrangement: 100% onsite presence to facilitate real-time collaboration, immediate escalation management, and direct operational continuity.

High-Impact Scientific Mission: Directly safeguard the quality and efficacy of life-transforming advanced biologic and molecular products.

Elevated Technical Scope: Drive key decision-making across data review, complex root-cause investigations, and method acquisition rather than routine bench execution alone.

Collaborative Onsite Culture: Work within a tight-knit, interactive laboratory setting designed for immediate feedback, hands-on problem solving, and mutual mentorship.

Cross-Functional & External Visibility: Collaborate closely with Quality Assurance, global CMO partners, external testing sites, and site operational leadership.