Quality Control Microbiology Manager

3 weeks ago

philadelphia, United States Planet Pharma Full time

Quality Control Microbiology Manager needed


Summary:

The Manager, Quality Control (QC) Microbiology, is responsible for oversight of day-to-day microbial QC operations at Cell Therapy Center (iCTC). The role will be responsible for working in a GMP- regulated environment and have good understanding of QC microbiology test methods and environmental monitoring. This role must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to: lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures.


Shift:

  • Monday to Friday from 11:00pm to 7:30am


Essential Functions and Responsibilities:

  • Manage several analysts at the iCTC in the day-to-day cGMP QC testing of drug products for lot release and stability; Manage microbial testing at contract laboratories
  • Manage the technical transfer, qualification, and validation of microbiology test methods for in- process materials, lot release, and/or stability, as needed
  • Manage the environmental monitoring program for the facility
  • Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.
  • Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
  • Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
  • Support product stability programs including generation of stability protocols, execution of stability testing, stability data analysis, and final reporting of stability data.
  • Support of site contamination control programs.
  • Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
  • Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
  • Support site qualification/validation/commissioning activities, as needed.
  • Serve as a qualified trainer, as needed.
  • Support career development of microbiology team members.
  • Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification
  • Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment
  • All duties are performed with minimal supervision and oversight

Required Education, Skills, and Knowledge:

  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
  • Minimum (8) years of experience in the biopharmaceutical industry within a Quality Control role
  • Experience managing a team a plus
  • Broad knowledge of biological drug development with respect to Quality Control
  • Demonstrated ability to manage external partners with respect to quality control activities
  • Successfully interface with multi-disciplined teams in a global setting
  • Extremely detail-oriented with strong analytical, written, and verbal communication skills
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • Demonstrate sense of urgency; ability to recognize time sensitivity
  • Flexible and adaptable style with an eagerness to take on challenges
  • Problem solver who not only identifies issues but leads efforts to resolve them

Preferred Education, Skills, and Knowledge:

  • Experience with cell therapy products

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