Lead Development Chemist

Lead Development Chemist - Permanent - Clayton, NC

Proclinical is seeking a Lead Development Chemist to join a leading Contract Manufacturing Organization. This is a permanent position located in Rochester, NY.

Primary Responsibilities:

This role involves performing method validation and development, managing complex projects, and improving lab quality systems. The successful candidate will provide analytical support to commercial products and manufacturing and serve as a technical resource for QA laboratories. The role also involves providing technical leadership, problem-solving, and process/product improvements in support of current commercial manufacturing and packaging operations.

Skills & Requirements:

• Bachelor's degree in life science or closely related discipline with 10+ years of experience, or Master's degree with 7+ years of experience, or PhD with 5+ years of experience.
• Experience in a regulated industry, preferably pharmaceutical.
• Previous experience in a cGMP environment.
• Proven success in method development and validation.
• Familiarity/competency in areas such as HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution.
• Experience in regulated development process & regulatory requirements.

The Lead Development Chemist will:

• Minimize commercial lab & manufacturing downtime by conducting incident investigations, identifying corrective/preventative measures, and coordinating documentation.
• Collaborate with internal groups to implement preventative measures to reduce/eliminate repetitive deviations.
• Provide analytical leadership and consultation internally and serve as an analytical lead for customer and government regulatory agency site inspections.
• Coordinate work of lab personnel to support on-time delivery of analytical data to projects.
• Perform analytical method development, validation, and project support from design to execution.
• Provide analytical solutions to manufacturing troubleshooting, process development, and improvements.
• Evaluate regulatory changes to existing methods and investigate new technologies and analytical approaches for utilizing existing in-house instrumentation to improve test efficiency/effectiveness.
• Manage the Analytical Development Laboratory, provide coaching and guidance to staff, and develop methods to transfer information and techniques from training sessions to actual on-the-job performance.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.