Location: Monroe,NC, USA
Handle all aspects of the stability program, including sample management and stability oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents. Write, execute, and manage the stability program in support of all sterile manufacturings (prefilled syringes/vials). Ensure program is in alignment with FDA, ICH, WHO and other international agencies. Manage and facilitate completion of all stability-related tasks, including sample request, receipt, labelling, lay down procedure, calculation and execution of stability pulls. Organize and execute shipments to off-site storage and/or laboratory facilities. Coordinate with QC management for scheduling of stability sample analysis. Ensure data is managed and evaluated, including the creation, review, and trending, to meet company, industry and regulatory requirements. Review and approve change controls, deviation, investigation, out-of-trend or out-of-specification reports. Manage stability chambers, including daily monitoring and excursion evaluation. Write and maintain SOPs in support of the stability program. Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability and Quality Control departments. Represent Glenmark as appropriate in FDA, notified body, internal and other regulatory audits. Work in close
collaboration and support with other members of the CMC team responsible for drug product development and support to management. Evaluate and continuously improve stability systems, quality and compliance with regulatory requirements, best practices, and quality systems procedures. This position supervise a Sr. Stability, QC Analyst and a Stability, QC Analyst.
Qualifications and Requirements:
* Applicant must have Masters Degree in Pharmacy, Pharmaceutics or Biotechnology.
* Applicant must have five (5) years experience in Pharmaceutical Quality Control Laboratory environment, including experience with conducting stability studies.
* A minimum of 4 years of laboratory managerial experience, including involvement with regulatory audits is also required.
* Applicant must have strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), cUSP and ICH Q1A (R2).
* Experience with electronic systems such as Trackwise, SAP and/or other relevant QMS systems are required.
* Experience with Lab Equipment such as UPLC, HPLC, and GC and Software such as Empower or Lab Solutions are required.
* Applicant must have experience with statistical applications for stability data evaluation and shelf-life determination.
* Strong documentation skills are required, including writing SOPs, technical papers and investigations.
* Knowledge and experience in all aspects of quality system management, lean manufacturing skills and managerial experience in Oral solid dosage and parenteral pharmaceutical manufacturing process is required.
* Applicant must have experience supervising and guiding internal resources during stability testing and troubleshooting and acting as a back-up for routine Testing.
* Proficiency with Microsoft Word, Microsoft Excel and Power Point are required.
* Strong knowledge of Pharmaceutical Development Process with multiple dosage forms: Oral Solids, Liquids, Injectables, Lotions, liquids, foams, Creams, Ointments and Sprays is required.
* Strong organizational and communicative skills are imperative.
* Domestic travel 10%.
40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States.
To be considered, please visit Glenmark Pharmaceuticals career site website at