Laboratory Production Manager

Laboratory Production Manager

Laboratory Production Manager's main responsibilities include : maintain oversight of laboratory staff and day-to-day laboratory activities, support operations, quality, special projects, and support other parts of the business as needed. This position collaborates with Production management providing feedback on sample requests and QA / QC activities related to operations and makes overall decisions on data release and process changes. Develops policies, procedures and the business work plan for the laboratory and quality assurance while driving the laboratory in meeting performance metrics. Maintains initiatives to improve workflows, customer service levels, and increase attention to environmental, health and safety issues throughout the laboratory and facility.

The Laboratory Services Manager has advanced knowledge of pharmaceutical dosage forms, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) Out of Specification (OOS) handling, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA) and Analytical Testing Methods. Capable of assisting in method development / validation of dosage forms and facility improvements.

Manager Duties and Responsibilities

• Manages and is responsible for the day-to-day operations and success of the QC Laboratory including sample processing / intake, microbiology, and chemistry sections
• Conducts candidate screening, interviewing, hiring and onboarding of new personnel and helps identify where FTE is needed for the success of the laboratory, conducts terminations of employees as needed
• Monitors employee performance for day-to-day activities and performance goals. Oversees supervisors / leads and provides guidance, coaching, and training for their development and progression and performs performance evaluations, mentoring and development of skills of Laboratory Personnel
• Develops and supervises staff through provision of timely feedback and use of appropriate Human Resource policies and tools to facilitate and ensure the ability of staff to achieve highest level of professional growth and desired performance standards
• Serves as a point of escalation for issues requiring discretion to resolve both personnel and laboratory related
• Monitors productivity reports and time management reports to ensure laboratory is meeting benchmark metrics (KPIs and OKRs)
• Maintains oversight of testing volume to ensure service standards are met and maintained, including lab sample turnaround time which includes 3rd party testing
• Strong knowledge of maintenance, calibration, and function of HPLC-DAD, LC-MS, and TOC instrumentation.
• Identifies problems (both personnel and technical) that may adversely affect test performance or reporting of test results, and determines solutions
• Partners with production to anticipate workloads and overall efficiencies of the laboratory and represents Laboratory Services in cross-functional meetings and projects
• Implements programs, processes, and operational improvements to enhance the level of internal and external customer service provided
• Collaborate with Quality Assurance to help coordinate training and oversees / conducts training for specified topics related to laboratory functions
• Assist in the development and maintain compliance of SOPs, forms, and other laboratory documentation, policies, and procedures as well as instrument calibration and maintenance
• Participates in conjunction with laboratory Leads / Supervisors, Quality Assurance and the Laboratory Director in implementation of GLP-FDA, USP, ICH and ISO regulations and guidelines to ensure laboratory is compliant and current
• Coordinates with QA for external audit readiness with regular reviews of personnel training, records, and other documentation that may be reasonably expected to be requested during an audit
• Assists Quality Assurance in the execution of Internal and External Audits, plans and executes responses to bring any out of compliance findings into compliance
• Ensures adherence to departmental operations and capital budgets, may assist in operational decisions, departmental budget development, reconciliation, and capital expenditure tracking
• Coordinates with Technical Manager for the use of laboratory personnel and equipment for the execution of special projects and testing that falls outside the regular scope of QC testing and procedures
• Assists Technical Manager for the transfer of methods, techniques, and instrumentation between teams.
• Assists Technical Manager and Quality Assurance with technical trainings and assessments between associated laboratory teams.
• Generate and provide appropriate explanation and documentation of testing as appropriate to respond to external inquiries regarding testing methods, BUD determination etc.
• May participate in qualification of suppliers in accordance with guidance documents
• Helps to select and negotiate terms of contract with outside vendors, purchase of equipment and contracts for services provided at 3rd party contract laboratories, acts as point of contact for maintenance contracts and other supply vendors
• Maintains equipment maintenance and calibration either internal or 3rd party
• Responsible for organization of laboratory space, inventory, and personnel.
• Performs and updates cost-per-test analysis that informs test charges for new and existing tests
• Provides financial analysis of send-out costs vs. in-house costs for specific tests and advises upper management team of opportunities for in-sourcing of laboratory tests and services, identifies opportunities to bring testing in-house
• Assists in evaluation of new instrumentation and / or methods as required in order to improve laboratory testing performance and may oversee the troubleshooting / problem solving of instruments and methods
• Aid in the development, implementation, and communication of departmental mission, vision, and strategic plan
• Establishes and tracks departmental goals in conjunction with Quality Director, Quality Assurance, corporate goals, and vision

Skills and Qualifications

, USP

, GFI 256 Compounding Animal Drugs and Bulk Drug Substances, and ISO 17025 practices, policies, guidance's, and regulations