Manager, QC Microbiology - EM/UM 896 (Contract)
About The Position
The Environmental Monitoring and Utilities Monitoring Technical Support role provides subject matter expertise to the EM/UM team. It serves as a key organizational resource for technical expertise in EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards. The position reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT). This is a 12-month temporary contract assignment with a chance to extend, onsite Monday through Friday, 9 a.m. to 5 p.m. The listed pay range is $65–$72 per hour, and the role is eligible for overtime pay in accordance with federal and state requirements. The selected individual will be employed by a third-party agency partner on assignment at Vertex Pharmaceuticals; compensation, medical benefits, fringe benefits, and other employment terms will be presented by the agency partner upon offer.
Requirements
- Bachelor’s degree in Microbiology or a related field.
- At least 7 years of industry experience in Microbiology in a biotechnology and/or Cell and Gene Therapy organization.
- Extensive knowledge and experience with Quality Control methods and compendial requirements, including sterility, endotoxin, environmental monitoring, identification, and APS/PAQ processes.
- Strong understanding of aseptic processing and contamination control strategies in manufacturing facilities.
- Extensive experience working in a GMP environment.
- Strong communication and scientific writing skills.
- Strong project management skills.
Nice To Haves
- Experience with electronic systems such as LIMS and Quality Management Systems (Veeva).
Responsibilities
- Demonstrate understanding of sampling and microbiological testing methodologies, including EM, UM, bioburden, endotoxins, sterility, Gram stain, and identification programs, in accordance with relevant regulatory standards.
- Provide hands-on technical expertise with microbiology laboratory instruments, including Vitek, Endosafe, BacT, MALDI-TOF, and isolators.
- Organize, plan, and support team members with technical questions and problem-solving to promote group efficiency and accountability.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and Health, Safety, and Environmental policies per Vertex standards.
- Provide subject matter expertise for Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
- Manage deviations and implementation of Corrective and Preventative Actions (CAPA) associated with microbiological methodologies.
- Support laboratory inspections and audits, address follow-up actions, and promote continuous improvement.
- Collaborate with Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development to support alignment and effective communication.
- Provide guidance in drafting EM/UM trend reports.
- Provide technical guidance to EM/UM analysts on document revisions and other EM/UM-related projects.
- Draft studies, protocols, and risk assessments as needed to support EM/UM operations.
- Assist with document revisions.
Benefits
- Overtime pay in accordance with federal and state requirements
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What This Job Offers
Career Level
Manager
