Carex is partnering with a Pharmaceuticals industry partner to find a Team Leader, IPCs & Validations to join their Quality Control structure under the Quality Assurance Organization. This leadership role involves supervising and mentoring QC chemists while supporting analytical testing of pharmaceutical in-process manufacturing samples and validation activities related to drug substances and drug products. The Team Leader will contribute both scientifically and operationally, ensuring compliance with cGMP and ICH guidelines while collaborating cross-functionally to ensure project efficiency and scientific accuracy.
What You’ll Do
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Provide leadership, mentorship, and performance management to a team of QC chemists.
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Guide professional development and foster a collaborative, innovative, and inclusive work environment.
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Support method validation, transfers, and testing of pharmaceutical products, ensuring regulatory compliance.
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Perform and oversee analytical techniques including HPLC, GC, LC-MS, KF, FTIR, Raman spectroscopy, and endotoxin testing.
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Participate in technical discussions and scientific problem-solving sessions.
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Collaborate closely with QA, Analytical Development, and Manufacturing teams to align on timelines and deliverables.
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Identify, troubleshoot, and resolve instrumentation and testing issues.
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Author and review technical documents including deviations, CAPAs, and investigation reports.
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Ensure proper training and compliance with SOPs, protocols, and cGMP regulations.
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Maintain laboratory instrumentation, including calibration and maintenance coordination with metrology.
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Act as a backup to Senior Laboratory Management as needed.
What You’ll Bring
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Master’s degree in Chemistry (or related field) with 5+ years of relevant lab experience, or a Bachelor’s degree with 7+ years of experience.
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Demonstrated expertise in cGMP and ICH laboratory standards and operations.
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Proficiency in analytical instrumentation and test methodology, including method validations and transfers.
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Strong leadership skills and the ability to mentor entry- and mid-level chemists.
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Excellent communication skills, both verbal and written, with experience drafting technical documents.
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Ability to interpret data trends, solve scientific problems, and lead cross-functional collaboration.
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Proficiency in Windows-based software including MS Office and chromatography data systems.
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Strong mathematical, analytical, and documentation skills.
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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