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Job Summary
The Lab Director supervises and manages a manufacturing production team consisting of microbiome process associates and assistants, a quality assurance professional, and bioengineers responsible for performing technical laboratory procedures to support biomanufacturing of live biotherapeutics (LBPs) for early phase FDA-approved clinical trials. The ideal candidate will work with scientists, industry partners, and clinicians involved in highly innovative, translational, early-stage clinical investigations focusing on microbiome reconstitution/augmentation with lyophilized commensal bacterial strains in a range of clinical scenarios. The director will have accountability and responsibility to lead the end-to-end manufacturing process, consisting of key unit operations such as master cell banking, fermentation, harvest, lyophilization, and milling of LBPs. A key component of the role will be FDA documentation for GMP manufacturing, including authoring, reviewing, and approving batch production record and general suite/operational activity SOPs and supervising analytical biological assays to assess the stability and integrity of LBPs. In addition, the ideal candidate will be responsible for the optimization of lyophilization procedures for anaerobic bacterial strains, procedures for manufacturing LBP capsules, and documentation of product quality, purity and stability, as well as documentation of cGMP activities while consistently maintaining workplace safety by providing supervision and training for cGMP staff.
Responsibilities
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through 7 years of work experience in a related job discipline.
Preferred Qualifications
Education:
Experience:
Preferred Competencies
Full Time
$134k-174k (estimate)
06/23/2024
07/10/2024
apexsystems.com
SAN BRUNO, CA
200 - 500
1995
Private
JOE ZONE
$500M - $1B
Business Services
Apex Systems is a consulting firm that offers hiring, staffing, and workforce management solutions for technology companies/
The following is the career advancement route for Lab Director positions, which can be used as a reference in future career path planning. As a Lab Director, it can be promoted into senior positions as a Top Laboratory Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Lab Director. You can explore the career advancement for a Lab Director below and select your interested title to get hiring information.