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Job type: Permanent

Discipline: Biological Sciences

Location: United States

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

�� 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

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

�� Staffing is an equal opportunity employer.