Sr Manager, QC Microbiology


El Segundo
Permanent
USD157000 - USD175000
Quality
PR/544081_1746548442
Sr Manager, QC Microbiology

This growing biotech company dedicated to developing innovative treatments for advanced cancers and infectious diseases. Their mission is to improve patient outcomes through cutting-edge research and development.

They are in search of a Senior Manager, Quality Control (Microbiology) who will oversee the microbiology quality control activities to ensure the safety and efficacy of our products. This position will manage the microbiology laboratory operations, ensuring compliance with regulatory standards and company policies.

Position Summary

The Senior Manager, Quality Control Microbiology role provides QC-Micro leadership for the company's early phase (phase I/II) clinical and commercial manufacturing operations, Contract Manufacturing Organizations, and Contract Testing Laboratories. This role is responsible for overseeing all GMP QC Microbiology activities supporting clinical and commercial manufacturing operations which includes maintenance of QC Micro sections for global regulatory applications, as well as regulatory support functions for inspections or information requests. Specific areas of responsibility include, but are not limited to, design and oversee: the environmental monitoring program (EM), the personnel monitoring program (PM), all in-process and release testing (microbiology), all raw materials testing (microbiology), method establishment of microbiological assays, aseptic processing training program, utilities testing program (microbiology), facilities qualification (EMPQ), and cleaning validations. This position interacts cross-functionally with the Manufacturing, Facilities, Engineering, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.

Professional Experience

  • Bachelor's degree in microbiology or biology, with a minimum of10+ years of microbiology/sterility control required; or
  • Master's degree in microbiology or biology, with a minimum of 8+ years of microbiology/sterility control required.
  • 7+ years of management experience required
  • Experience qualifying GMP manufacturing facilities (EMPQ, utilities qualification and validation) required
  • Experience managing Contract Testing Laboratories required
  • Experience hiring, training, and leading cross-functional teams required
  • Experience in aseptic manufacturing operations within a GMP regulated Biologics or Pharmaceutical environment required
  • Experience with a start-up pharmaceutical company preferred.
  • Experience with the simultaneous management of multiple products through early phase clinical trials preferred

If you believe you'd make a good fit for this role, please apply in directly.

FAQs

Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.

Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.

We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business. 

That's why we recommend registering your resume so you can be considered for roles that have yet to be created. 

Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.

Handpicked roles for you