Description
Develop, manufacture, and ensure the quality, safety, and regulatory compliance of pharmaceutical products in industrial settings. Formulate and scale up drug products, oversee cGMP production and quality control, and provide expert guidance on dosage forms, interactions, stability, and labeling to cross-functional teams and regulators.
- • Review product formulations, master batch records, and specifications for accuracy, suitability, and cGMP compliance.
- • Advise cross-functional teams on dosage forms, drug interactions, stability, and safety for labeling and use.
- • Analyze utilization and safety data to monitor adherence, detect signals, and prevent misuse or harmful interactions.
- • Procure and qualify APIs, excipients, and packaging; manage GMP inventory and storage conditions.
- • Maintain complete GMP documentation, including batch records, stability data, controlled substance logs, and change controls.
- • Develop and optimize formulations; scale up processes from lab to pilot and commercial production.
- • Oversee compounding and manufacturing operations or supervise technicians to ensure accurate weighing, measuring, and mixing.
- • Collaborate with R&D, QA/QC, regulatory, medical, and clinical teams to design, monitor, and improve products and regimens.
- • Execute process, cleaning, and sterilization validation; establish critical process parameters and acceptance criteria.
- • Manage aseptic processing and sterile fill-finish activities, including environmental monitoring and media fills.
- • Plan and enforce SOPs for mixing, packaging, labeling, serialization, and proper waste disposal.
- • Conduct stability studies per ICH; assess identity, strength, purity, and potency to support shelf life and release.
- • Lead quality control testing and product release; investigate deviations, OOS/OOT results, and implement CAPA.
- • Prepare and review CMC sections of regulatory submissions; respond to agency queries, audits, and inspections.
- • Oversee technology transfer to internal sites or CMOs; manage quality agreements and supplier qualification.
- • Develop medication guides, IFUs, and educational content; author technical reports and publications.
- • Provide medical information to healthcare professionals and route adverse events to pharmacovigilance.
- • Train and mentor staff or interns on cGMP, data integrity, and safe handling of potent or hazardous drugs.
- • Support demand planning and supply continuity; ensure cold chain and controlled storage as required.
- • Maintain and troubleshoot QMS, LIMS, and ERP data systems to ensure traceability and data integrity.
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Healthcare & Human Services
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
