Job Description

As Chemistry Lab Manager you will be managing and coordinating the stability program strategy, including planning stability program approach, training, and providing scientific rationale & acceptance criteria. You will own department programs and documents including SOPs, Work Instructions, Protocols and Reports, as well as generate/review/approve revisions required based on company procedures, current industry standards, and regulatory requirements.

• Ensures optimal analytical testing, inclusive of sample preparation, sample analysis (e.g., via HPLC & FTIR) and providing reporting to Quality Director.
• Establish and develop analytical competence for personal care wipes business.
• Conduct analytical tests on raw materials, final products and customer samples concerning previously unknown substances, their presence, storage, degradation, etc., and recording and maintaining this in the database.
• Develop, apply, and maintain quality standards for sample testing processes, documents, methods, and procedures that comply with ISO regulations, GLP guidelines, and FDA guidance.
• Meet frequently with management to deliver presentations, protocols, reports, and all other data to keep the team current on all projects and equipment schedules.
• Manage and monitor activities of workers engaged in performing chemical, incoming inspection, and finished goods tests to obtain data for qualifying raw materials, blended materials, and finished goods.
• Train talent on operational aspects to ensure accuracy of reporting, instrumentation maintenance and troubleshooting as well as the acquisition of new instrumentation to expand current capabilities.
• Conduct performance reviews, ensure staff development, and administer corrective action as appropriate.
• Ensure timely project management to enable prioritization of workload.
• Work with leadership to coordinate cross-team functions and operations with the department laboratory.
• Work independently with project assignments, or collaboratively on group projects/programs
• Perform other duties as required.
• Manage collection of data to support KPIs.
• Coordinate OOS investigations and monitor process to ensure that appropriate actions are taken and are sustainable.
• Represents the company in a positive and professional manner during regular customer and vendor site visits, and external audits.
• Insures adherence to safety rules. Report and correct unsafe practices and situations.
• Assess impact of proposed changes to qualified production equipment, laboratory instruments/equipment, utilities, facilities, and validated processes.
• Support process/product improvement initiatives to optimize throughput and improve asset efficiency.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual\'s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Join a North American Manufacturer of Personal & Home Care Products |Position Reports Directly to Director of Quality

• BS degree in Chemistry.
• Experience using data analysis software and laboratory information management systems.
• Previous experience in a laboratory management role, preferably in a highly regulated industry, is a plus.
• Six (6) years method development and sample preparation and/or appropriate laboratory experience recognized by a laboratory accrediting body is preferred.
• Knowledge of stability ICH guidance is preferred.
• Prior experience coordinating and/or executing stability program requirements is preferred.
• A minimum of four (4) years\' experience with HPLC and FTIR instrumentation is preferred.
• Ability to manage multiple assignments related to laboratory operation.
• Prior experience working in a GMP environment.
• Experience with various analytical software platforms; previous work with platforms such as Waters Empower Software and Perkin Elmer is a plus.
• Ability to supervise, lead, and train personnel.
• Must be able to work in a challenging fast-paced environment while maintaining strong attention to details.
• Excellent verbal and written communication skills with scientific and non-scientific team members is required; scientific writing experience preferred.
• Analytical focus with the ability to collect and interpret chemistry data.
• Strong knowledge and expertise of Microsoft Office
• Strong organizational skills with the ability to multitask and prioritize competing demands.
• Ability to comply with established safety standards for the proper use, safe handling, and disposal of harmful chemicals, substances, and hazardous wastes.

Our Client is a reputable manufacturer of personal & home care products, committed to producing high-quality and safe products for their customers. Products consist of unit dose, disinfectant wipes, all-purpose cleaners, facial wipes, and baby wipes. The Organization has 9 facilities in North America. Throughout the years, the company has built robust quality systems, multiple GMP certifications, and in-house FDA/EPA microbiology, quality control, chemistry, and R&D labs.

Our Client offers a competitive salary with an excellent benefit package, including medical, dental, vision, vacation, paid holidays, life insurance, etc.

If you are a dedicated quality professional with FDA experience, looking to make a significant impact in the personal care industry, we invite you to apply for the position. Join our Client\'s team and contribute to our mission of delivering exceptional products that enhance the well-being of our customers.

Michael Page