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Manager, Quality Control (QC) Microbiology

Proclinical
Philadelphia, PA Full Time
POSTED ON 1/23/2025
AVAILABLE BEFORE 4/18/2025

Manager, Quality Control (QC) Microbiology - Permanent - Philadelphia, Pennsylvania

Proclinical is seeking a Manager, Quality Control (QC) Microbiology to lead microbial QC operations in a dynamic and collaborative environment.

Primary Responsibilities :

The successful candidate will play a pivotal role in managing activities within a GMP-regulated environment, ensuring adherence to cGMPs and regulatory standards throughout the product development lifecycle. This position offers an exciting opportunity to work with cutting-edge cell therapies in the oncology sector.

Skills & Requirements :

  • Bachelor's degree in biological sciences or a related field.
  • A minimum of 8 years of Quality Control experience in the biopharmaceutical industry.
  • Proven ability to manage teams and external quality control activities.
  • In-depth understanding of biological drug development and cGMP regulations.
  • Exceptional analytical, organizational, and communication skills.
  • Ability to multitask, prioritize, and work in a high-paced

The Manager, Quality Control (QC) Microbiology's responsibilities will be :

  • Manage a team of analysts performing cGMP QC testing for drug product lot release and stability.
  • Oversee microbial testing conducted at contract laboratories.
  • Lead technical transfer, qualification, and validation of microbiology test methods.
  • Manage the environmental monitoring program and ensure timely trend analysis and reporting.
  • Supervise site contamination control programs and maintain a microbial identification database for facility isolates.
  • Author, review, and approve SOPs, protocols, reports, and specifications.
  • Lead investigations for out-of-specification results and implement corrective actions.
  • Support stability programs, including protocol generation, data analysis, and reporting.
  • Establish and maintain effective relationships with internal teams and external partners.
  • Serve as a qualified trainer to support the development of microbiology team members.
  • Participate in site qualification, validation, and commissioning activities as needed.
  • Identify and resolve technical issues related to GMP quality control.
  • Drive performance management processes, including regular reviews and issue resolution.
  • Compensation :

  • 138 000.00 - $160 000.00 Per Annum
  • Salary : $138,000 - $160,000

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