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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