Director, Product Quality - United States
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- Our company is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.
- Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.
- We are on a rapid growth trajectory and have a highly energized and accomplished team.
- The successful candidate will become a Product Quality Director for company’s Early Phase programs.
- The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. Early Phase programs encompass programs starting at pre-IND through commercial site transfer.
- As a product expert in Quality, the Product Quality Director has responsibility for overseeing a group of cross-functional personnel to ensure all aspects of phase appropriate activities are managed. Product Quality Director will help to set operational/organizational strategy and may also have responsibility for providing technical input for late-stage and commercial regulatory files, comparability studies, RTQs, specifications and PQ operational strategies.
- As a product expert in Quality, the Product Quality Director has responsibility for working directly with Operations Leaders, International Expansion (IE), Quality Control (QC), corporate Quality, Regulatory, Process Development (PD), Quality Assurance (QA), etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to product(s).
- Provide strategic and operational direction on behalf of Product Quality to Early Phase programs through strong scientific leadership related to global regulatory filing strategies, analytical comparability and specifications.
- Exhibit the capacity to communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
- Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
- Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
- Exhibit an ability to work and navigate within an evolving scientific and regulatory environment.
- Doctorate degree and 4 years of directly related experience OR
- Master’s degree and 8 years of directly related years OR
- Bachelor’s degree and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- B.S. in biochemistry, biology, or a related protein/biotechnology sciences field 10 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environment, OR
- an Advanced degree in biochemistry, biology, or a related protein/biotechnology sciences field and 7+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience.
- 10+ years working in a regulated environment (either direct GMP or technical support)
- 4 + years experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation.
- 4 + years experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- Experience in Project Management in support of biopharmaceutical development.
- There is a strong preference for candidates who are familiar with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions.
- Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful.
- Knowledge of analytical techniques used for biologics product quality control with a particular preference for experience in analytical comparability assessments to support manufacturing changes.
- Understanding of cell therapy and drug product development and manufacturing.
- In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.
- Previous experience working on a cross-functional team in a matrix environment is a plus.
- Excellent written and verbal communication skills, including facilitation and presentation skills are important.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of the first 200 employees in this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.