Analytical Lab Manager - 228124

Currently hiring for a Laboratory Manager with a strong analytical chemistry background with LC-MS and GC-MS. This opportunity is be joining a growing pharmaceutical manufacturer and have the opportunity to help build out the Analytical Chemistry department.

Roles & Responsibilities

• Oversee the setup and day-to-day operations of the mass spectrometry (MS) lab within a cGMP-compliant environment. This includes managing workflows, personnel, and deliverables for LC-MS and GC-MS analyses of OTC drugs, dietary supplements, cosmetics, and Rx pharma products.
• Develop and implement MS lab best practices, standard operating procedures (SOPs), work processes, and reporting templates. Ensure that all practices meet regulatory requirements and quality standards.
• Create and validate mass spectrometry and chromatography parameters and methods for the quantitation of analytes using LC-MS and GC-MS. Write, review, and update SOPs and oversee method development and validation.
• Act as the go-to expert for Scientech’s mass spectrometry, GC-MS, and LC-MS technologies. Provide guidance and expertise in these areas.
• Train MS Lab Associates on new methods, instruments, and SOPs. Manage and oversee daily lab operations, ensuring timely and accurate delivery of results.
• Identify and select the best vendors for equipment, reagents, and disposables. Install and set up LC-MS, GC-MS, and other MS lab capabilities.
• Coordinate and support the installation, qualification (IQ/OQ/PQ), calibration, and maintenance of MS lab equipment and instrumentation.
• Ensure the production of high-quality data for testing results across various MS methods and platforms. Conduct daily quality control reviews of MS lab results.
• Represent the MS lab during internal, client, and regulatory body audits. Address any issues related to MS procedures, including out-of-specification (OOS) results and deviations.
• Recruit, train, and manage MS Lab staff, including conducting annual performance reviews. Lead troubleshooting efforts for lab issues and manage investigations into OOS results.
• Maintain and troubleshoot GC-MS, LC-MS, and other MS lab equipment as needed.

Requirements:

• Education & Experience: PhD in Chemistry or related Life Sciences field preferred, with 5+ years of MS lab experience including significant management responsibilities. Experience in an FDA cGMP-regulated environment is highly preferred. Alternatively, an MS degree with 10+ years of experience, including 5+ years in a management role within a cGMP-regulated setting, will be considered.
• Technical Expertise: Extensive experience with maintaining and troubleshooting a range of analytical lab instruments, including single quadrupole, triple quadrupole, and advanced MS systems interfaced with LC and GC platforms. Proficient in a variety of analytical services such as quantitation, potency testing, residual solvents, extractables & leachables, nitrosamines, pesticides, bioanalytical studies, pharmacokinetics, and metabolism studies.
• Skills: Demonstrated ability to work independently, build programs and platforms, and solve complex problems. Proven track record of functioning well under high-stress conditions in a rapidly growing environment. Excellent interpersonal, communication, and leadership skills. Ability to prioritize tasks and adapt to a dynamic work environment.