Associate Director, Quality Control Microbiology

Job Description

General Summary:

The Associate Director of QC Microbiology will provide oversight to a team of EM/UM managers and analysts responsible for routine sampling and testing across 4 commercial and clinical manufacturing sites. As a Subject Matter Expert (SME) for Microbiology this role will serve as a key resource within the organization, providing technical expertise in the areas of microbiological testing, aseptic processing, and contamination control for the manufacturing process in accordance with regulatory standard.  This role reports to the Director of Quality Control in Cell and Genetic Therapies (VCGT), and will be a critical link between Analytical Development, Clinical and Commercial manufacturing, Quality Assurance, and Technical Operations.
 

Key Duties and Responsibilities:

• Oversee the environmental/utilities monitoring program, and coordinate the activities and priorities of the assigned team to meet the required business timelines. Serve as the primary point of contact for communication to CMC leadership

• Demonstrates a strong understanding of microbiological testing methodologies including but not limited to 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.

• Develop strategies for microbiology method trending and routinely monitor assay performance to ensure data integrity and consistency

• 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 change controls, 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

• Plan and manage resources and budget, including capital expenditure (CapEx) requirements

• Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication of quality control activities

• Provide technical expertise and leadership to drive continuous improvement and innovation
   

Knowledge and Skills:

• Flexibility to cover different shifts and weekends as required by business needs

• 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, scientific writing, and presentation skills

• Experience with electronic systems such as LIMS, MODA, and Quality Management Systems (Veeva) preferred

Education and Experience:

• Bachelor Degree in Microbiology or related field.

• A minimum of 10 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization, and  6+ years of increasing management responsibility in a Quality Control environment. Equivalent combination of education and experience also considered.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]