Sr. Director, Quality Technical Services
We are looking for an experienced expert in product development lifecycle and validation to lead the Quality Technical Services function. We specialize in T-cell therapeutics for oncology and have multiple early and late phase clinical trials in the US and Europe. Direct experience in establishing the validation lifecycle for Advanced Therapy Medicinal Products (ATMP), particularly in the area of cell therapy is essential, as is experience in product control strategy development, equipment qualification, aseptic processing, analytical methods (particularly Flow Cytometry) and application of risk assessment in development of lifecycle strategies.
location: Philadelphia, Pennsylvania
job type: Permanent
salary: $230,000 - 240,000 per year
work hours: 9 to 5
- Key strategic leader responsible for the T-Cell and Vector Lifecycle Management functions within the Quality Unit. The primary focus of the leader will be to advance comprehensive lifecycle strategies in support of early and late phase product portfolio.
- In collaboration with technical heads in Quality Control, Process Development, MS&T and Manufacturing, establish and maintain essential lifecycle documentation including QTPP, Control Strategy, risk assessments, validation plans, protocols, and associated reports.
- Define and execute strategies for effective stewardship of analytical methods used for vector and drug product release, stability and characterization.
- Ensure regulatory claims are supported with applicable data and actions
- Serve as the subject matter expert for the product development lifecycle applicable to vector and T-Cell processes with particular focus on strategies that facilitate innovation within the product portfolio.
- Ensure that external contract manufacturers understand and implement requirements for validation and lifecycle documentation.
- Establish strategies required for control strategy development including establishment of critical process parameters, proven acceptable ranges, and critical quality attributes in order to facilitate regulatory submissions including IND, IMPD, MAA and BLA.
- Provide company representation at regulatory and industry organizations involved in setting standards for the advancement of ATMPs toward commercialization.
- Responsible for the Specification Committee and key member of the Material Review Board.
- Degree in Engineering or Science, PhD in cell/molecular biology preferred.
- Experience in biologics, vaccines, or gene/cellular therapy field.
- 10+ years' experience in leading/managing multidisciplinary teams.
- An effective strategic leader with a clear record of having managed a diverse portfolio of company critical projects.
- Experience managing analytical methods transfer, qualification, and validation for biological products. Specific experience with potency assays for cell therapies is strongly desired.
- Deep experience supporting the development of regulatory documentation including IND, IMPD, BLA and CTD. Experience with post approval changes is desired.
- Experience in face-to-face communications with regulatory agencies including direct experience representing complex validation strategies to regulators.
- Experience leading the commissioning, validation and start-up of aseptic processing facilities.
- A passion for addressing the critical unmet medical needs of patients.
- Recognized expert in the application of the process validation lifecycle supporting complex biologic products.
- Deep understanding of and experience establishing validation strategies compliant with current European and US FDA guidance for process validation.
- Expertise in worldwide requirements for manufacturing, analytical methods, stability, and technology transfer.
- Expert in technology transfer, qualification, and validation of compendial and bespoke analytical methods with a particular understanding of assays used for cell therapies.
- Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
- Strong communication skills and a "do-what-it-takes" attitude that inspires others.
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.
skills: Quality control, Quality Assurance, Biology, Flow Cytometry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.