Analytical Group Leader - Topeka, United States - Germer International

Germer International Topeka, United States

4 weeks ago

Description

Our client, a pharmaceutical organization in Alabama, is looking to add an Analytical Group Leader to their team.

The Analytical Group Leader in QC/R&D plays a pivotal role in ensuring the quality and efficacy of pharmaceutical products through effective leadership and analytical expertise.

This position involves overseeing the analytical operations within the Quality Control (QC) and Research & Development (R&D) departments, driving continuous improvement initiatives, and maintaining compliance with regulatory standards.

Key Responsibilities:
Lead a team of analytical chemists and scientists, providing guidance, mentoring, and technical support.
Foster a collaborative and high-performance culture within the group, promoting teamwork, accountability, and professional development.

Oversee the development, optimization, and validation of analytical methods for the analysis of pharmaceutical products, ensuring accuracy, precision, and reliability.

Stay abreast of industry advancements and regulatory requirements to enhance analytical methodologies and techniques.

Manage QC activities related to raw material testing, in-process monitoring, and finished product analysis to guarantee compliance with specifications and standards.

Conduct investigations into out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs) as necessary.
Coordinate analytical testing for new product development projects, ensuring alignment with project timelines and objectives.
Ensure adherence to regulatory guidelines and requirements (e.g., FDA, ICH, USP) throughout analytical activities, documentation, and reporting.
Participate in regulatory inspections and audits, addressing any findings and implementing corrective measures as needed.
Oversee the maintenance, calibration, and qualification of analytical instruments and equipment to ensure accuracy and reliability of results.

Qualifications and Skills:
Bachelor's, Master's, or Ph.
D. degree in Chemistry, Pharmaceutical Sciences, or related field.
5+ years of experience in a pharmaceutical analytical laboratory, with a focus on QC and/or R&D.
Strong leadership skills with demonstrated experience in team management and development.
Expertise in analytical method development, validation, and troubleshooting.
Proficiency in analytical techniques such as HPLC, GC, FTIR, UV-Vis, dissolution testing, etc.

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