Senior Specialist, QC Microbiology
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual to join us as a Sr. Specialist in the QC Microbiology Laboratory, supporting the Newark Quality Control Organization. In this role you will support, perform and / or coordinate standard microbiology tests for clinical and commercial manufacturing of drug products in a GMP work environment. The selected individual will be responsible of supporting the raw materials, in-process and final drug product microbiology testing programs. Candidates must be well versed and be able to execute and coordinate various microbiological techniques including product safety assays and rapid microbiology test methods, with reference to cell therapy products.
Responsibilities include, but are not limited to:
- Establish, validate, and sustain a microbiology safety testing program for product and raw materials in a GMP Quality Control Laboratory.
- Work with internal and external resources to maintain the laboratory in an optimal and compliant state.
- Manage the qualification and validation of microbiology methods including rapid microbiological methods.
- Monitor and trend data
- Assemble reports from environmental monitoring program of Allogene’s cGMP facility. Frequently update management on environmental trends. Implement corrective action plans, when necessary.
- Support the generation of CoAs for product release
- Assist in the preparation of dossiers and data packages for interactions between Allogene and Regulatory agencies.
- Interact with Inspectors from Regulatory agencies and participate in Pre-Approval Inspections.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Assist in investigations regarding out of specifications (OOS) results. Address and manage deviations related to micro processes and / or procedures.
- Communicate updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Coach and train other analysts to qualified level.
- Contribute to continuous improvement opportunities for methods optimization, coordinating re-validation, and drafting SOPs, where necessary. Troubleshoot methods and analytical instrumentation; improves existing methods to optimize efficiency wherever possible. Establish /maintain and minimize workload, streamlining existing systems and ensuring adherence to all appropriate internal and external guidance.
- Lead method validation and transfer activities for the QC Microbiology group and support instrument qualification activities. Serve as point person for the group.
- Maintain close interaction and communication with various cross-functional groups within and outside of the Quality Control Microbiology organization to ensure on-time and dependable related decisions.
- Interact with regulatory agencies, customers, and internal auditors/inspectors.
- Represent QC Microbiology at operational and cross-functional meetings; prepare and present information; provide decision making at meetings and disseminate information back to QC Micro Lab.
- Participate in technology transfers, new products introductions, microbiology methods qualifications and method validations, as required.
- Gather metrics information for use in continuous improvement of areas of responsibility.
- Perform other duties within QC, as required.
Position Requirements & Experience:
- Bachelors Degree (BS) in Microbiology (preferred) or related scientific field with 10+ years of Quality Control Laboratory experience, or Masters in Science (MS) with 8+ years of QC lab experience or Ph.D. and 5+ years of QC Microbiology lab experience.
- Leadership skills and experience is highly desirable
- Must have experience with Quality Systems such as Laboratory Investigations, Deviations, CAPA, Change Control and Risk Assessments Tools.
- Experience authoring SOPs, protocols, and technical reports to support operations within QC Microbiology Laboratories.
- Experience in laboratory techniques such as Sterility tests, Bacterial Endotoxins, and genus and species identification of microorganisms.
- Working knowledge of regulatory requirements (21 CRF Part 11/210/211) and trends
- Strong knowledge of GMP, SOPs and quality control processes.
- Working knowledge of aseptic processing.
- Experience supporting equipment and utilities IQ/OQ/PQ/PV.
- Proficient in MS Word, Excel, Power Point, and other applications.
- Ability to work independently and as part of a team.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong written and verbal communication skills.
- 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.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.