ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
This role will provide technical and organizational leadership to develop analytical testing solutions in support of product and platform development for ArsenalBio cell therapies. The AD team plays a key role in delivering a critical scientific approach to understand and optimize cell product attributes that improve patient outcomes. Establishing and managing work plans to achieve goals for analytical method development across all cell therapy products, including applications of methods to stability and comparability protocols. You will assure lot release and characterization assays are developed and implemented in compliance with FDA regulations and other jurisdictions and assure appropriate method qualification and transfer to QC and support validation. The role will author and/or review method sections of CMC regulatory submissions and represent the analytical function in regulatory interactions regarding parenteral product development. Importantly, he/she will have experience developing assays to quantify strength, purity and potency of cell therapy products, preferably engineered T cells. The successful candidate must have successfully demonstrated leadership, technical proficiency, scientific creativity, initiative and collaboration skills.
What you will do:
• Develop strong functional partnerships and phase appropriate strategies with other corporate functions and execute on aligned strategies to support clinical development and commercialization plans.
• Accountable for the success of analytical development operations to deliver on the aligned priorities of the organization.
• Lead the design and execution of phase-appropriate analytical strategies including analytical method development, justification of specifications, reference standard characterization, product characterization and establishment of test methods to enable product QC and batch release, extended characterization, formulation development, comparability assessments and stability programs for iPSC derived NK and T cell products from the development stage to commercialization.
• Implement a testing infrastructure to partner with other technical operations teams in the delivery and interpretation of analytical data.
• Collaborate with QC to establish and execute overall analytical lifecycle management strategy.
• Avoid delays and ensure accuracy of data through prompt resolution of technical issues, troubleshooting, review deviation events and assay failure investigations in coordination with internal and external QC, QA, and regulatory groups, as appropriate.
• Provide technical input for OOS and OOT investigations.
• Drive continuous improvement to the test methods through technological innovation to support ongoing product development effort.
• Provide technical support to internal and external cGMP analytical operations.
• Support global regulatory filings that relate to analytical development.
• Support product-related inspections for US and foreign regulatory agencies as needed.
What you will bring:
• Ph.D. in relevant Science with 10+ years of industrial AD experience, or MS, BS with equivalent experience.
• Experience with analytical development of cell/gene therapy in various stages of development (preclinical to commercialization).
• Extensive analytical method development, troubleshooting, and validation experience. In depth experience with the development and validation of analytical methods (flow cytometry, PCR, ELISA and cell-based bioassay, cell therapy potency assay etc.).
• Strong knowledge of GLP and cGMP, worldwide regulatory requirements, current industry practices and cell/gene therapy CMC activities.
• Solid understanding of current industry trends and regulatory expectations associated with analytical science areas, including but not limited to stability studies, microbial control, comparability evaluation, cell-based assays, potency assays and method validation.
• Understanding of technology transfer including transitioning of research assays into cGMP analytical methods and tech transfer existing or new testing methods to internal and external manufacturing facilities.
• Experience preparing and updating regulatory filings (IND, BLA, MAA).
• Demonstrated experience building and leading exceptional teams.
• Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision.
• Successfully demonstrated leadership, technical proficiency, scientific creativity, initiative and collaboration skills.
• Ability to effectively communicate scientific and technical concepts, program objectives, data analysis within a matrix environment.
• Knowledge of Quality by Design, Process Analytical Technologies and Six Sigma systems and approaches is desirable.
We are committed to hiring the best talent. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.