Job Description

Responsibilities

Actively ensures changeovers from development, all operations, processing, maintenance, environmental monitoring, and integration with the Quality Assurance Unit are consistent with departmental SOPs and regulatory requirements. Performs qualifications, processing and provides training to staff for all cGMP equipment, facilities, and processes. The GMP Manager will manage assigned staff, processes and QA/QC practices including continuous quality improvement, with appropriate documentation and competency assessment and verification intervals.

• Management of assigned staff including training, feedback, timeclock, scheduling, workload coverage and annual performance reviews.
• Provides onboarding and staff training and ensures documentation of competency assessments. 
• Consistent interface and training initiatives for staff professional development and department growth.
• Interface with the other departments in teamwork to ensure organizational consistency.
• Participates in meetings related to responsibilities and communicates effectively.
• Monitor utilization and yield operating levels and lead efforts to maximize Overall Equipment Effectiveness (OEE) & cost reduction.
• Dashboard style key performance indicators.
• Develop and update monthly reports that accurately summarize performance.
• Draft and update Human Applications Lab SOPs, technical reports, and GLP/GMP documentation related to job functions in an updated electronic environment.
• Maintains QA / QC for the Human Applications Laboratory including the update of key performance indicators. Ensures that policies/procedures, QC and equipment are all current and in compliance with regulatory agencies.
• Maintaining proper documentation and records.
• Documents changes via the change control process.
• Investigation and resolution of non-conforming product and material events, or other CAPAs; manufacturing data analysis; quality risk management; start-up protocol/process validation/verification planning; and routine problem-solving.
• Ensures compliance to established procedures and processes.
• Recommends and implements continuous improvement projects that support department quality & organization objectives.
• Initiates and follows up on CAPA and quality nonconformance (QNC).
• As required, helps maintain the site Master Validation Plan.
• Cell processing and manufacturing, including but not limited to, cell selection, cell culture, cryopreservation and various bio-analytical testing. Example: optimization of cell expansion protocols in various culture systems, characterization of cell products by flow cytometry. 
• Processing leukapheresis, blood, biopsies, body fluids, and other biospecimens. 
• Problem solving through technical/team leadership.
• Support client needs, requests and projects.
• Maintain inventory monitoring and levels. Reagent and supply ordering.
• GMP Biobank.
• Adherence to applicable FDA regulations of Good Manufacturing Process (GMP), Good Laboratory Practices (GLP), Good Tissue Practices (GTP), and American Association of Blood Banks (AABB) Accreditation Cellular Therapy Standards, Foundation for Accreditation of Cell Therapy (FACT) inspection for Immune Effector Cell Standards Accreditation and International Society of Cellular Therapy (ISCT) guidelines, best practices for cellular therapy products.
• Other human applications lab duties and projects as assigned.

Qualifications

5 years of GMP experience including broad experience in a Quality, Manufacturing, Research or Regulatory function

Manufacturing and Research functions AND technical quality skills in at least two of the following areas: CAPA/problem-solving, applied statistics, validation, risk management/FMEA, change management, design controls, engage repeatability and reproducibility, supplier quality management, and/ or demonstrated application of LEAN/ Continuous Improvement skills

OSHA Training

HIPAA Training

IATA Hazardous Materials Shipping Certification

Education Requirements:

Bachelor of Science or Engineering in relevant field

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