Associate Director, Newark Validation Head
Quality | Newark, CA | Full Time
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 world-class 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.
The Associate Director, Newark Validation Head will be responsible for developing, implementing and managing equipment qualification, process validation, filling validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. This position will be based out of Newark, CA.
Responsibilities include, but are not limited to:
- Establish/maintain a high-level overview of state of equipment qualification and process validation across the business. Establish project prioritization.
- Partner with Quality based on feedback (e.g. via regulatory inspections, changes in regulations) to establish a common approach and translate that for the validation function.
- Partner with Production to define the process validation/ equipment qualification interface.
- Establish an escalation process to address difficult validation and technical challenges.
- Support link with Development to be able to tap into knowledge repository (e.g. for late life cycle products)
- Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities
- Active participation in driving the development/application of a consistent training approach for validation
- All related SOPs are created and updated on time.
- Ensure the right validation capabilities are in place to support technical transfer activities.
- Provide support in resourcing capital investment projects for validation activities.
- Represent Allogene in all activities relevant to validation (e.g. harmonization of standards).
- Directly support qualification and validation activities by creating and executing protocols.
- Approve all qualification and validation protocols and reports.
- Ensure that all respective validation activities are performed and are in line with the current Allogene requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from major or complex changes.
- Benchmark against external industry standards with the aim of achieving best-in-class standards and practices, expand and share knowledge throughout Allogene.
- Participate in transfers and launches, liaise with technical development to align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
- Support equipment process qualification for new technologies. Ensure consistency with process needs defined by Production and/or PD.
- Participate in improvement and remediation of products.
- Develop budget for validation activities.
- Support developing high performing validation team
Position Requirements & Experience:
- Bachelor’s degree required
- 7-10 years of experience in manufacturing/ manufacturing science and technology/technical development/Quality.
- Thorough understanding of product processes
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Expert in reviewing and writing technical reports.
- Excellent communication skills / technical writing
- Strong knowledge of PC based applications: Word, Excel, PowerPoint
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; stoop, kneel or crouch.
- Specific vision abilities required by this job include close vision, and the ability to adjust focus
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 may 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.