Laboratory Manager

Overview:

Position Title : Laboratory Manager

Business Title : Laboratory Manager

Entity : Consumer Products Services Division

Department : CPS - ATL

Location : Milford, Ohio

Reports to : Vice President

FLSA : Exempt

Hours Worked : Typically, Monday through Friday, forty-hours per week.

Position Summary:

ATL is seeking a dynamic Laboratory Manager to join our team of dedicated professionals focused on client service and quality. The lab services both analytical chemistry and microbiology for consumer goods, OTC healthcare, pharma and medical device industries. Practical knowledge of microbiology and experience with USP microbiology methods is preferred. Facility is FDA-registered with quality systems covering both GMP and ISO certification.

Duties and Responsibilities:

It is everyones responsibility to live out our Values and Absolutes

by Shaping a World of Trust while ensuring responsible progress.

• Efficient and effective planning of workflow in the microbiology and analytical chemistry laboratory. Ability to delegate tasks and workload in a manner that ensures the timely completion of testing and scheduled laboratory tasks.
• Laboratory tasks include but are not limited to: routine laboratory maintenance, SOPs reviews, re-training etc; effectively delegate non-scheduled events such as projects; proactively evaluate laboratory workflow for continuous improvement opportunities to enhance efficiency and effectiveness of the services we provide to our clients.
• Maintain and/or establish metrics for the Laboratory to understand and manage the efficiency and effectiveness of the group and/or individuals. Utilize these metrics to mitigate risks, improve performance, and/or to celebrate group accomplishments.
• Maintain and ensure compliance with cGMP and ISO 17025 systems. Ensure compliance with applicable SOPs, review, and revision of SOPs, test methods etc. Creation and/or review of protocols, technical reports, data collection sheets, logbooks, and raw data. Ensure employees are properly trained in labs systems, methods, SOPs etc.
• Proactively evaluate the laboratorys quality systems for gaps in current compliance standards and/or industry trends for compliance. If gaps are identified, mitigate these gaps. Capable of hosting tours of the micro-laboratory by regulatory or client auditors and serve as a microbiology Subject Matter Expert (SME) if called upon.
• Participation in client interactions and support client requested initiatives; may include internal studies and special projects; write protocols, interpret data, and/or write technical reports; work with client services to build relationships with existing clients, expand relationships with existing clients, and strive to provide opportunities for the client to have an exceptional experience.
• Proactively develop staff. Coach and provide feedback on job performance. Complete annual performance evaluations and identify development opportunities. Assist with training new hires and cross-train existing staff. Identify and develop strong performers in the microbiology laboratory to establish next generation of management and/or technical leaders
• Responsible for initiating and/or conducting investigations for OOS, deviations, CAPAs, change controls according to the quality system. Identify trends related to laboratory as cause OOS investigations and deviations, and conduct CAPA to eliminate these trends. Develop staffs technical and/or problem-solving skills (investigational) skills to drive for root cause.
• Maintain a safe work environment in a GMP/FDA-regulated environment according to OSHA Laboratory Standard. Comply with the Chemical Hygiene Plan and accident reporting. Establish systems for ensuring a high-level lab hygiene.
• Managing the business of the Laboratory. Awareness of business laboratorys performance against annual fiscal/budgetary targets. Manage resources to exceed annual fiscal/budgetary targets.
• Keep abreast of new technologies and/or compliance trends related to the lab. Propose and potentially lead efforts to implement new technologies and/or mitigate gaps in the labs cGMP systems.
• Perform other essential tasks, projects, and responsibilities as required.

Skills & Proficiencies:

• Practical experience in lab operations (optimization & development)
• Experience troubleshooting & problem-solving. Familiarity with maintaining and operating specific laboratory instruments is preferred.
• Practical experience with USP methodologies for consumer goods, medical devices and industrial chemicals.
• Demonstrated equipment and method validation experience.
• Experience in the cosmetic and medical devices industries is a plus
• Strong written and verbal communications and interpersonal skills
• Excellent organizational skills to organize / prioritize individual and team workload to meet or exceed deadlines
• Ability to juggle multiple tasks and changing priorities in a very busy environment
• Strong analytical / problem solving / process improvement skills
• Strong knowledge of technical field
• Proficiency with Word, Excel & PowerPoint
• Excellent attention to detail
• Conflict resolution skills
• Champions company values
• Project management skills
• Stakeholder management skill
• Continuous improvement mindset

Education and Experience:

• Experience working in a regulated environment.
• 5 + years of relevant experience.
• 2 + years of management experience.
• Bachelor's Degree in relevant field

An equivalent combination of educationa and experience may be accepted in liau of above.