Manager/Senior Manager, Quality Control Microbiology

Who we are looking for:

Vor Bio is seeking a Manager/Senior Manager, Quality Control Microbiology to be responsible for the day-to-day management of the personnel and work of the QC Microbiology group and the operation of the QC Microbiology laboratory performing microbiological testing (e.g., sterility, mycoplasma, and bioburden tests) for batch release of Vor's advanced therapeutics including cellular and gene therapy products. The role is also responsible for the environmental and utilities monitoring program of multiple cleanroom suites, including establishing EM programs, collecting and testing samples, and trend analysis. The successful candidate will have sufficient experience with microbiology and environmental monitoring programs to take a lead in establishing the overall programs at Vor to enable internal manufacturing. The candidate will work collaboratively with department managers, directors, and VPs to support corporate strategic objectives.

Key areas of responsibility:

• Ensure adherence to cGMP practices for QC Microbiology laboratory operations and testing performed by QC Microbiology group
• Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits
• Schedule day to day EM/Micro operations of QC personnel and equipment to support the client's manufacturing in the GMP manufacturing facilities
• Responsible to define and create EM policies, programs, and procedures as necessary
• Assure staff are appropriately trained to perform their work assignments and responsibilities
• Foster an empowering environment where team members develop innovative solutions that improve performance, gains team support for change
• Responsible to act as the lead for the overall environmental monitoring programs and related microbiology testing to support both the internal manufacturing facility as well as the product(s) of Vor
• Supervise personnel to achieve optimal productivity and proficiency, including setting personnel goals in alignment with department and company objectives
• Manage timely generation of the periodic reports for cleanroom environment, utilities, and microbial isolates
• Lead investigations for EM excursions, microbial investigations, and out of specification results and recommend/assist in implementing appropriate corrective actions
• Implement and maintain quality systems and assures their area of responsibilities comply to those system
• Responsible to lead the microbiology related testing that occurs with both Vor's EM program as well as product support (internal and external microbiology and viral related testing)
• Provide subject matter expertise to enhancement and management of the environmental and utilities monitoring programs to support the maintenance of utilities and cleanrooms in conjunction with other departments to ensure cGMP compliance and state of control

Qualifications:

• Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively,
• Proficiency with MS Office, MS Project, PowerPoint
• Experience in managing relationships with internal departments, external vendors, and partners in a collaborative, constructive manner
• BSc, MSc, PhD or equivalent life sciences degree with a minimum of 10 years pharmaceutical industry experience including 7 years in Quality Control EM/Micro related role(s)
• Experience with cell and gene therapy products preferred
• Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
• Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities
• Extensive knowledge of cGMP and ICH requirements for pharmaceutical development and manufacturing, including technical knowledge of analytical and standard compendial physical, chemical, and microbiological methods
• Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
• Open, available, transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
• Experience in defining and creating procedures/policies/strategies for environmental monitoring for pharmaceutical manufacturing facilities
• Experience with rapid sterility method (ex. BacT Alert systems) is preferred