The primary responsibility of this position is to plan, organize, and manage the day to day operation of the clinical laboratory staff, ensuring compliance to established procedures and regulations.
Responsibilities will include, but are not limited to, the following:
· Work to coordinate daily laboratory tasks assuring all laboratories are sufficiently staffed to complete daily product workload.
· Develop and implement technically sound Clinical Manufacturing batch records, SOPs, protocols, and specifications as required, while adhering to good documentation practices (GDP).
· Serve as the Subject Matter Expert (SME) and use knowledge of scientific techniques to troubleshoot processing or product quality issues with a sense of urgency.
· Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with project timelines and production schedule.
· Lead, develop, and coach clinical laboratory staff, including training staff within ISO 7 and ISO 8 environments.
· Ensure overall inspection readiness for area of focus.
· Lead the receipt of technical transfers from Process Development (PD) Team, ensuring appropriate equipment purchase, assisting with processing COGs and timelines, and initiating laboratory set-up.
· Lead deviation investigations and support on-time closure of deviations and CAPAs for areas of focus.
· Report to work on-time and demonstrate good interpersonal and communication skills.
· Establish and maintain strong working relationships with cross-functional teams.
· Ability to multi-task and prioritize in a fast-paced environment, regardless of challenges.
· Maintain working knowledge of cGMP/FDA requirements and adhere to compliance policies and regulations.
· Ability to work a flexible schedule when required.
- BS.in Biology, Biochemical, Chemical or Biomedical Engineering or related discipline
- 5+ years of relevant experience in cGMP cell culture manufacturing, with 3+ years as a team lead or supervisor.
- Must have previously participated in aseptic gowning qualifications.
- Strong knowledge of aseptic technique, cell culture processing including expansion, isolation, separation, washing, harvesting and cryopreservation required.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics/cell therapy.
- Ability to read and interpret documents such as safety procedure/rules and standard operating procedures (SOPs).
- Must be able to communicate effectively with other functional areas and accrediting and regulatory agencies.
- Must have excellent organizational skills and ability to handle multiple tasks.
- Highly motivated, willingness to acquire new skills, and ability to work with minimal supervision.
- Must have strong engineering or scientific knowledge appropriate for processing clinical grade cellular therapeutics.
- Ability to work holidays and weekend, when needed.
- Ability to consistently perform various manual laboratory duties and techniques on time sensitive material with accurate and precise manipulations.
- Involvement with SOP and Batch Record development.
- Thorough understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
- Excellent verbal and written communication skills.
- A basic knowledge or various computer applications. Ability to work with Microsoft Word and Excel required.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing, and occasional lifting of heavy materials.
To extract maximum value from the most biocreative single event in life