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

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 99,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks an Environmental Monitoring and Utilities Monitoring Technical Support SME to provide expert technical guidance in EM/UM sampling, testing, aseptic processing, and contamination control. The role reports to the Associate Director of Quality Control in Cell and Genetic Therapies.

You will support cross‑functional teams, handle OOS/OOT investigations, CAPA implementation, and assist with inspections while ensuring compliance with cGMP and Vertex standards.

Qualifications

• Bachelor’s degree in Microbiology or related field.
• 7+ years of industry microbiology experience in biotech/cell and gene therapy.

Responsibilities

• Provide SME-level technical support for EM/UM sampling, testing, aseptic processing, and contamination control.
• Ensure cGMP compliance and Health, Safety, Environmental policies.
• Support investigations (OOS/OOT) and CAPA.
• Assist with inspections, audits, and follow-up actions.
• Draft EM/UM trend reports and revise related documents.
• Collaborate with Manufacturing, QA, Regulatory CMC, and Analytical Dev teams.

Skills

Environmental Monitoring

Microbiology testing

cGMP compliance

Regulatory knowledge

Project management

Scientific writing

Cross-functional collaboration

Education

Bachelor’s degree in Microbiology

7+ years industry experience in Microbiology

Tools

LIMS

Quality Management System – Veeva

Job description

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
• Manages 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 guidance in drafting EM/UM Trend Reports
• 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
• Strong project management skills
• 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.

Contract Length: 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