Head of Quality Control
Quality | South San Francisco, CA | Full Time
Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.
Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 17 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in South San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from the investment consortium of TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, Gilead and Pfizer. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a leader to build and oversee the Quality Control function. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The leader of QC will have a pivotal role in creating a novel QC capability, incorporating well understood biotechnology analytics with first in class cellular and molecular methods. This position will require active engagement in this strategic vision for the company. The position will be responsible for oversight and management of contract test labs performing GMP lot release and stability testing of Allogene products, as well as the design and build out of the internal QC function and systems This role will be responsible for transfer and validation of bioanalytical methods for cell therapy products; responsible for raw material testing, in-process, stability and final product testing. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Excellent communication skills and demonstrated ability to work well with others will be essential. The leader will report to the Head of Quality.
Responsibilities include, but are not limited to:
- Provides functional leadership including hiring and managing a professional, high performing QC staff designed to meet the technical and compliance requirements of a growing company.
- Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to contract-test labs (validation of methods and tech transfer of methods, including comparability)
- Develop necessary laboratory systems and documentation (e.g. SOPs) to perform QC operations in an effective and compliant manner.
- Oversight and management of contract test labs performing GMP lot release and stability testing of Allogene products
- Develop in-process and final specifications for drug substance and drug product of Allogene cell therapy products.
- Establish raw material specifications and internal testing capability for Allogene sourced raw materials.
- Establish user requirements for procurement and qualification of QC analytical equipment.
- Prepare data packages, technical reports, and relevant CTD sections in support of regulatory agency submissions.
- Develop and approve method qualification/validation protocols and reports.
- Develop and approve stability master plans, protocols, and reports.
- Conduct and or oversee investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures and laboratory operations.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Develop and implement annual quality plans, departmental goals, action plans, and budgets.
- Independently report quality metrics to executive management through Management Review process.
- Drive continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
- Internally collaborates with research, clinical, process development, and manufacturing groups.
- Externally collaborates with contract service providers and corporate partners in support of supply chain objectives.
- Other duties as assigned.
Position Requirements & Experience:
- At least 10 years in a technical role in QC, manufacturing, QA or analytical development and at least 5 years in a related management role, leading technical staff.
- Bachelor’s degree in Engineering, Chemistry or biological sciences required. Advanced science or engineering degree highly preferred.
- Education, training, or experience in cell and gene therapy a plus.
- Lean or Six Sigma certification preferred but not required.
- Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
- Experience with setting up and successfully managing cell-based assays is highly preferred.
- Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
- Knowledge of statistical tools for monitoring assay variability, setting product specifications and expiry dating.
- Proficient in MS Office, Visio, Project, and statistical software.
- Working knowledge of LIMs applications and experience with implementing LIMS in the QC environment.
- Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is preferred).
- Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- 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 relationship building, conflict resolution, and 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.#LI-KN1