Manager, QC Microbiology - EM/UM 896

Atrium; Boston (MA); On-site; USD 90,000 - 99,000; Full time

Job summary

Vertex Pharmaceuticals in Boston, MA seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert microbiology support within QC. The role focuses on EM/UM sampling, testing, aseptic processing and contamination control under regulatory standards.

Reports to Associate Director of QC in Cell and Gene Therapies. The candidate will guide EM/UM analysts, handle OOS/OOT investigations, CAPA, audits, and cross-functional collaboration across Manufacturing, QA,

Qualifications

• Bachelor's degree in Microbiology or related field required.
• 7+ years of industry Microbiology experience in biotech/cell and gene therapy.
• Strong knowledge of QMS and regulatory standards.

Responsibilities

• Provide SME-level technical support for EM/UM, including sampling and microbiological testing.
• Guide investigations of OOS and OOT; manage CAPA for microbiological methods.
• Support cGMP compliance, audits, and inspections; communicate with cross-functional teams.

Skills

Microbiology expertise

cGMP knowledge

Quality Control

Scientific writing

LIMS experience

Education

Bachelor's degree in Microbiology

Tools

LIMS

Veeva

Job description

The Environmental Monitoring and Utilities Monitoring Technical Support role will provide technical support for EM/UM team as a Subject Matter Expert (SME). This role will serve as a key resource within the organization, providing technical expertise in the areas of EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards. This role reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT).

Key Duties and Responsibilities:

• Demonstrates a strong understanding of sampling and microbiological testing methodologies, including but not limited to EM, UM, Bioburden, Endotoxins, Sterility, Gram Stain, and Identification program per relevant regulatory standards
• Hands-on experience in the handling of microbiology lab instruments i.e., Vitek, Endosafe, BacT, MALDI-TOF, Isolator
• Organize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountability
• Ensure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per Vertex standards
• Provide subject matter expertise in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
• Manage deviations and Corrective and Preventative Action (CAPA) implementation associated with Microbiological methodologies
• Support laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvement
• Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication between teams
• Provide technical guidance to EM/UM analysts in performing document revisions and other EM/UM related projects
• Draft studies/protocols/risk assessments as needed to support EM/UM operations
• Assist with document revisions

Knowledge and Skills:

• Extensive knowledge and experience of Quality Control methods and compendial requirements, including but not limited to (Sterility, Endotoxin, Environmental monitoring, ID, 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
• Experience with electronic systems such as LIMS and Quality Management Systems (Veeva) preferred

Education and Experience:

• Bachelor's degree in Microbiology or related field.
• A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.

12 months with the chance to extend.

Pay Range

$65/hr.-$72/hr.

Shift/Hours

Monday-Friday, 9-5 onsite

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements