Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.
This position responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC Microbiology staff. They are responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/ Clean Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The supervisor keeps laboratory management informed of all departmental activities and product related events.
Key Responsibilities include but are not limited to:
- Manages daily activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.
- Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development.
- Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
- Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures.
- Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.
- Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
- Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications.
- Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT).
- Assures department is equipped with functional, calibrated equipment and necessary supplies.
- Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
- Represents the QC Microbiology department in cross functional teams and internal/external meetings.
- Assumes other duties and responsibilities as assigned.
Education & Experience:
- B.S. in a Life Sciences discipline preferably Microbiology with 8 years of experience working in a GMP Quality Control role, with 2 years of supervisory experience
- Experience with viable and non-viable Environment Monitoring collection instruments, techniques and qualifications/validations. Concentration of experience in implementing aseptic technique and contamination control strategies
- Experience with Microsoft Office
- Strong attention to detail
- Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
- LIMS experience preferred