Manager, QC Microbiology - EM/UM 896 (Contract)

Atrium Works•Boston, MA

9d•Onsite

About The Position

The Environmental Monitoring and Utilities Monitoring (EM/UM) technical support role provides technical support to the EM/UM team as a subject matter expert (SME). The role serves as a key organizational resource, providing expertise in EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards. It reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT). This is a 12-month contract with the chance to extend. The schedule is Monday–Friday, 9–5, onsite. The role is a temporary assignment through a third-party agency partner, with an hourly pay range of $65–$72 and eligibility for overtime pay under applicable requirements. The agency partner presents compensation, medical benefits, fringe benefits, and other employment terms upon offer.

Requirements

Bachelor’s degree in Microbiology or a related field.
A minimum of 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.
Hands-on experience handling microbiology laboratory instruments, including Vitek, Endosafe, BacT, MALDI-TOF, and isolators.

Nice To Haves

Experience with electronic systems such as LIMS and Quality Management Systems (Veeva) is preferred.

Responsibilities

Demonstrate expertise in sampling and microbiological testing methodologies, including EM, UM, bioburden, endotoxins, sterility, Gram stain, and identification programs, in accordance with relevant regulatory standards.
Organize, plan, and support team members with technical questions and problem-solving to promote 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.