Senior Specialist, Quality Control, Chemistry (Data Review

Step into a critical analytical leadership and technical oversight role within a high-performing Quality Control Chemistry ecosystem. Reporting directly to the Senior Manager of QC Chemistry, you will serve as the technical anchor for cGMP data review, method lifecycle activities, and root-cause quality investigations supporting product release and stability. If you thrive on applying advanced analytical judgment to chromatographic and biophysical outputs, driving timely closure of complex quality events, and mentoring analysts in a fast-paced, 100% onsite GMP environment, this opportunity places you at the center of mission-critical biopharmaceutical operations.

Balancing thorough analytical data review, quality system ownership, and operational coordination, your core responsibilities will include:

Analytical Data Review & Release: Perform meticulous review and approval of executed analytical assay packages (paper and electronic), scrutinizing chromatographic outputs (HPLC, UPLC), spectroscopic/spectrometric data, and physical characterization assays.

Quality Systems & Investigations: Initiate, lead, investigate, and drive timely closure of Quality Events, including deviations, Out of Specification (OOS) results, laboratory investigations, CAPAs, and Change Controls.

Method Lifecycle & Troubleshooting: Support Method Qualification, Method Acquisition, method transfers, and development initiatives; lead troubleshooting efforts for complex analytical methods and instrumentation.

Operational Alignment & Evening Shift Support: Develop and manage capacity-monitoring tools, align QC resources with business priorities, and provide real-time decision-making, escalation management, and cross-functional coordination across internal labs and CMOs—including support during evening shift operations.

Technical Documentation & CoAs: Author, review, and approve SOPs, test methods, Certificates of Analysis (CoAs), stability data packages, instrument qualifications, and computerized system validation (CSV) documentation.

Audit Readiness & Mentorship: Provide compliance guidance to the QC Chemistry team, support regulatory audit preparation and responses, and coach junior analysts on analytical techniques and troubleshooting.

Education: Bachelor’s Degree (BA/BS) in Chemistry (strongly preferred) or a closely related scientific discipline.

Experience: Minimum of 5 years of proven Quality Control laboratory experience within the pharmaceutical or biopharmaceutical industry, operating under strict cGMP regulations.

Technical Expertise: Extensive hands-on and data-review experience with chromatographic techniques (HPLC, UPLC), spectroscopic/spectrometric methods, and physical characterization assays (e.g., Dynamic Light Scattering particle analysis, break-loose/gliding force, Container Closure Integrity Testing [CCIT]).

Quality & Regulatory Systems: Strong command of Good Documentation Practices (GDP), Data Integrity principles, and quality event management; working knowledge of FDA, EU/EMA, and ICH guidelines is preferred.

Languages: Strong proficiency in English (verbal and written) to navigate global documentation and collaborate seamlessly across international matrix teams.

Work Arrangement: 100% onsite presence to ensure real-time operational oversight, immediate escalation support, and direct laboratory collaboration.

High-Impact Scientific Mission: Directly safeguard the safety, quality, and release of transformative medicines reaching patients worldwide.

Elevated Technical Authority: Exercise high autonomy and technical judgment across data review, method qualification, and complex quality investigations rather than routine bench testing alone.

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

Cross-Functional & Global Visibility: Partner closely with Quality Assurance, international CMO networks, external testing laboratories, and site operational leadership.