Carex is partnering with a Pharmaceuticals industry partner to find a Quality Control Team Lead to oversee and support analytical testing activities across raw materials, in-process samples, finished drug substances and products, as well as stability studies. This role falls within the Quality Control structure under the Quality Assurance Organization and includes supervisory responsibilities over a team of chemists. The Team Lead will also support GLP toxicology and cGMP clinical trial material testing, providing technical guidance and operational leadership to ensure high-quality, compliant laboratory performance.
What You’ll Do
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Provide day-to-day leadership to a team of QC chemists, ensuring growth, development, and alignment with departmental objectives.
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Set performance expectations, deliver feedback, conduct evaluations, and foster a collaborative team environment.
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Serve as a subject matter expert in cGMP and ICH regulatory requirements, analytical instrumentation, and laboratory workflows.
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Lead and manage analytical testing for raw materials, in-process samples, finished products, and stability studies in support of GLP and cGMP programs.
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Collaborate cross-functionally with Analytical Development, QA, and Manufacturing to support method transfers and validation activities.
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Demonstrate proficiency in instruments such as HPLC, GC, LC-MS, KF, FTIR, Raman spectroscopy, and endotoxin plate readers.
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Guide troubleshooting of test methods, instrumentation, and analytical issues; lead root cause analyses and implement CAPAs.
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Author technical documents including OOS investigations, deviations, protocols, and CAPA reports.
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Ensure equipment calibration, maintenance, and troubleshooting in collaboration with metrology.
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Participate in scientific discussions, technical strategy sessions, and cross-functional leadership meetings.
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Track and trend analytical data and interpret stability results to support ongoing product evaluations.
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Train and mentor entry-level and mid-level chemists in analytical methods, instrumentation, and lab best practices.
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Serve as a backup to Senior Laboratory Management when required.
What You’ll Bring
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Master’s degree in Chemistry or a related field with a minimum of 5 years of relevant laboratory experience; or a Bachelor’s degree with at least 7 years of experience.
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Deep understanding of cGMP and ICH guidelines for laboratory operations and data integrity.
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Demonstrated expertise with a broad range of analytical instrumentation and test methodologies.
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Proven ability to lead, mentor, and manage chemists in a regulated laboratory environment.
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Proficiency with data acquisition systems and Windows-based software, including Microsoft Office and chromatography software.
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Strong technical writing and problem-solving skills; capable of performing complex calculations and interpreting scientific data.
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Excellent communication skills, with the ability to clearly convey technical information to diverse audiences.
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
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