Analytical Laboratory Manager

SCN BestCo•Mooresville, NC

About The Position

The Analytical Laboratory Manager supervises a team of analytical chemists and oversees method development, validation, and method verification activities. This role is responsible for coordinating chemical analysis and data review for intermediates, final products, formulation prototypes, pre-commercial stability samples, investigational samples, and plant trial samples, ensuring compliance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedures (SOPs). The position oversees the testing of pre-commercial release samples or for bioequivalence studies (BE) in accordance with cGMPs, GLPs, and SOPs.

Requirements

Bachelor’s degree in chemistry, biochemistry, or related science.
10 years’ experience in a quality control laboratory role or equivalent combination of higher education and relevant work experience.
5 years’ professional leadership, supervisory, and/or management experience.
In-depth, hands-on experience in various analytical techniques and instrumentation (e.g., UPLC, GC, UV, AAS, FTIR, ICP-MS, dissolution, etc.).
Thorough knowledge of cGMP regulations, good laboratory practices, laboratory management processes and procedures, and quality management systems for pharmaceutical operations.
Thorough knowledge of laboratory processes and relevant equipment.
Ability to work independently and determine appropriate resources to achieve business objectives.
Ability to work in a fast-paced, team oriented, ever-changing manufacturing environment while meeting deadlines.
Ability to analyze and prepare documents, reports, and correspondence.
Ability to process and handle confidential information with discretion.
Expertise in facilitation, problem solving, and analytical skills.
Proficiency in Microsoft Office including Word, Excel, Teams, and Outlook.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Must be able to demonstrate practical problem solving and trouble shooting skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Nice To Haves

5 years of experience in dietary supplement or a pharmaceutical cGMP laboratory.
General knowledge of USP monographs for product testing and techniques.
Experience with budget estimates and CapEx investment strategy.
Experience with Computer Systems Validation.
Experience with SAP.
Experience with electronic laboratory software systems.

Responsibilities

Plan and supervise the analytical development (AD) activities in the laboratory ensuring current regulatory and industry standards are met.
Oversee and actively participate in laboratory investigations, problem solving, and troubleshooting related to AD projects.
Manage all activities related to method development and validation along with the testing of intermediates, finished products samples for pre-commercial release or stability ensuring all activities occur in a timely and organized manner.
Ensure documentation is accurate, relevant, clear, concise, includes all necessary details, and is in accordance with cGMPs, GLPs, and SOPs.
Review and approve method verification, method validation protocols, reports, and analytical methods issued by the AD team for private labels and customer owned products.
Ensure a high standard of accountability for safety, SOPs, cGMPs, and housekeeping (including being “audit ready at all times”).
Work in close collaboration with Quality Control (QC) Laboratory Management, Research & Development (R&D) Innovation, Project Management, and other departments in respect to lab operations, product development analytical support, project timeline, adherence to timelines and budget.
Provide support to QC Laboratory operations for lifecycle management of analytical methods and remediation of legacy methods.
Initiate and coordinate analytical method transfer process from AD to internal QC Lab(s) or from AD to an external partner according to the existing procedures.
Drive the day-to-day scheduling of assigned AD personnel to meet testing cycle-times and commitments.
Develop, maintain, and report meaningful key performance indicators (KPIs) for AD activities.
Develop and implement the area SOPs, ensuring they are accurate and apply current best practices.
Ensure the equipment maintenance and scheduled calibration are maintained on the instruments used by the AD team.
Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
Prepare and present data summaries to internal and external stakeholders as needed.
Maintain budget including the approval of purchase orders (POs) for AD team expenses.
Direct supervision of ~12 employees.
Interviewing, hiring, and training employees.
Planning, assigning, and directing work.
Appraising performance, rewarding employees, and administering corrective actions.
Creating and sustaining a respectful and inclusive workplace, supporting open communication.
Addressing complaints and resolving problems.