Associate Director, Environment Monitoring and Microbiology

Allogene Therapeutics•Newark, NJ

9d•Onsite

About The Position

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: We are seeking a highly motivated Associate Director, Microbiology to join our team. You will work within the Quality team in supporting our efforts in an exciting area of cancer immunotherapy. The successful candidate will be actively engaged in managing and setting the strategic vision for the Quality Control Microbiology laboratory. The position will report to the Director, Quality Control and requires onsite presence 5 days per week at our manufacturing facility in Newark, CA.

Requirements

Bachelor’s degree in Microbiology or related field (advanced degree preferred) with at least 8 years of relevant experience in the biotechnology or pharmaceutical industry and at least 4 years in a management role
Strong theoretical and practical experience with various Microbiological methods including but not limited to sterility, growth promotion, bioburden, TOC, conductivity, endotoxin, viable and non-viable air monitoring, microbial identification, cell based and PCR mycoplasma testing
Excellent understanding of microbiological compendial requirements and pharmaceutical industry standards.
Strong understanding of cGMP requirements and QC systems
Experience in Aseptic Process and Contamination Control strategy in bio-pharmaceutical field required.
Experience with method development, verification, and validation
Strong technical writing skills with experience writing protocols, reports, discrepancies and/or deviations
Experience using MODA, LIMS system and laboratory automation.
Experience interacting with regulatory agencies, supporting GMP and PAI inspections as well as regulatory filings
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Ability to work independently and as part of a team
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Candidates must be authorized to work in the U.S.

Responsibilities

Responsible for the overall strategy, direction, oversight, planning, implementation and day to day operation of the Environmental Monitoring (EM)/Microbiology program and ensuring the compliant testing of raw materials, in process, drug substance and drug product for release and stability within agreed upon turn-around time (TAT)
Provide Quality functional leadership including hiring, developing, and managing, high performing quality control staff designed to meet the technical and compliance requirements of a GMP laboratory
Oversee the environmental monitoring program, microbiological methods and equipment, and manage routine environmental and utilities monitoring activities
Manage the MODA System for Water and EM and rapid technology for microbial methods and microbial identification to provide in-house testing
In collaboration with the validation team, drive the qualification of QC microbiology equipment
Responsible for technical decisions associated with the laboratory operations and projects as well as managing the generation, execution and technical review of analytical data and laboratory documents, ensuring that they are maintained in compliance with regulatory requirements
Serve as SME and qualifies on all methods utilized within the EM/Microbiology group
Ensure the safety of all team members by enforcing compliance with Health and Safety programs in place
Ensure that the QC EM/Microbiology laboratory is maintained in a constant state of compliance and is inspection ready at all time by conforming to all regulatory requirements and following routine 5S methodology
Other duties as assigned