Job Description

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

If you are having difficulty in applying or if you have any questions, please contact Annabelle Clark at a.clark@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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