Technical Laboratory Supervisor

The Technical Supervisors of the QC Laboratory main responsibilities include: maintain oversight of research and development/special projects within the laboratory, method development, method validation for both chemistry and microbiology departments, technical expertise, and training to all chemists and microbiologists. This position ensures the accuracy, reliability, repeatability, and compliance of analytical methods used for product quality assessment and validation. This position leads and oversees the development, qualification, and validation of analytical methods/methodologies use in laboratory testing and quality control of pharmaceutical products. The Technical Supervisor collaborates with cross-functional teams, including quality control, regulatory affairs, manufacturing, R&D formulations, quality assurance (QA) the product ideation team, production management, and Operations providing feedback on technical questions and requests related to active pharmaceutical ingredient (API) interactions, process changes and improvements, and product method/stability protocols. Provide scientific expertise and technical guidance to analysts involved over a range of laboratory tests including HPLC, Microbial Assay, Bioburden, Dissolution, Disintegration, Titration, Antimicrobial Effectiveness Testing and others. Helps run and maintain the laboratory environmental monitoring program in support of the client(s). Lead analysts to develop methods, new processes, and helps determine the best pathway forward for each product line. Maintains initiatives to improve the overall quality and acceptability of products, testing procedures, and operational processes. Provide leadership, mentorship and performance feedback to team members, fostering a collaborative, productive, and positive work environment.

The Technical Supervisor has advanced knowledge of pharmaceutical dosage forms, pharmaceutical manufacturing, Good Laboratory Practices (GLP), Good Manufacturing Practices, scientific method and study design, USP guidelines pertaining to validation and verification of methods, and analytical testing in both chemistry and microbiology. Capable of overseeing validation of dosage forms and facility improvements while meeting strict deadlines and adhering to United States Pharmacopeia (USP), Federal Drug Administration (FDA), International Council for Harmonisation (ICH) and International Organization of Standardization (ISO) regulations and guidelines. Strong verbal and written communication skills. Advanced knowledge in root cause analysis and corrective action/preventive action.

TECHNICAL MANAGER – DUTIES AND RESPONSIBILITIES

The following tasks are performed; however, other duties may be assigned.

• Manages and is responsible for the day-to-day operations and success of the Quality Control Laboratory technical team including microbiology and chemistry analysts.
• Conducts candidate screening, interviewing, hiring, and onboarding of new personnel and helps identify where full time employment is needed for the success of the laboratory technical team, conducts terminations of employees as needed.
• Monitors employee performance for day-to-day activities and performance goals.
• 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.
• Maintains oversight of special projects and ensures their accuracy and completion meeting desired timelines and milestones.
• Designs and develops study protocols in conjunction with the Laboratory Management for projects and processes.
• Identifies problems (both personnel and technical) that may adversely affect project performance or reporting of results and determines solutions.
• Represents Laboratory Services in meetings discussing product improvements, new product development and provides recommendations on the best options moving forward.
• Lead analysts in the development of new methods, validation processes, and procedures as well as instrument calibration and maintenance.
• Participates in conjunction with Laboratory Management 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.

• Generate and provide appropriate explanation and documentation of testing as appropriate to respond to external inquiries regarding testing methods, Beyond Use Date