Associate Director, Late Stage Analytical Development/Analytical Science & Technology (24013-B-683-MFG) - Arsenal Biosciences : Job Details

WHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Associate Director, Late Stage Analytical Development/Analytical Science and Technology to work onsite based in our Hayward office. ArsenalBio's mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer's inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients' lives.This means you'll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.We are seeking a talented and motivated Associate Director to join the ArsenalBio Technical Operations team (on-site position at our Hayward, CA location). The individual will serve as the liaison between Analytical Development and Quality Control to lead the technology transfer and qualification/validation of analytical methods, facilitate QC investigations, monitor QC assay performance and partner with Analytical Development and QC to establish raw material qualification and assay validation strategy in preparation for pivotal trial and BLA. This position will report into the Vice President of Process Sciences and will interact cross-functionally across the organization to enable the success of ArsenalBio.WHAT YOU'LL DO

• Build a late phase analytical strategy to support commercial cell therapy development
• Provide oversight of the assay improvement implementation in Quality Control.
• Establish analytical method monitoring and trending, and oversee the investigation of deviation and support QC assay root cause analysis and risk assessment.
• Analyze data, identify root cause and provide impact assessments as support for analytical method improvements and investigations.
• Act as Subject Matter Expert for QC equipment - supporting equipment set-up, commissioning and qualification (IQ, OQ, PQ), training, and troubleshooting technical issues.
• Establish qualification and validation strategy to facilitate assay establishment at QC consistent with the late phase requirements.
• Partner with AD and QC to establish raw material qualification strategy for process and QC materials.
• Support technology transfer activities, including, generation of risk assessments, QC test procedures, standard operating procedures (SOPs), and training materials.
• Develop and implement phase appropriate strategies for efficient analytical method transfers and verification/validation/comparability execution.
• Support regulatory filings, site readiness, and facility startup as needed.
• Keep detailed logs of studies to contribute to the dissemination of results.
• Author and review technical reports and source documentation supporting regulatory submissions.
• Good understanding of cGMP environment, Quality by Design (QBD) principles for process and assay development, qualification and validation required.
• Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges.
• Organize, communicate, and present complex data sets to key stakeholders and senior management.
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WHO YOU ARE

• PhD with 7+ years, Master's degree with 12+ years, or Bachelor's degree with 14+ years of experience in a scientific discipline related to biotechnology or pharmaceuticals, particularly in Analytical Development or Quality Control
• Demonstrated track record of successfully developing, qualifying, and transferring analytical methods
• Experience with method validation for late-stage clinical/BLA readiness/commercial settings is highly desirable
• Strong background in flow cytometry, cell-based assays, and other analytical methods for cell therapy products
• Strong grasp of statistical approaches for design of experiments (DoE) analytical method development, robustness testing, and data analysis
• Previous experience successfully managing multidisciplinary projects to meet program milestones and timelines
• In depth knowledge of US (required) and European (preferred) regulatory requirements for cGMP
• Expertise in transfer of methods to Quality Control, management of external vendors (central testing labs, contract manufacturing organizations), partnerships, with the ability to manage multiple technical projects successfully
• Excellent strategic thinking skills with demonstrated ability to successfully create and implement short and long range plans to support product development strategy
• Proficient in analyzing technical data and preparing written technical reports
• Excellent oral and written communication skills, detail-oriented, scientifically-driven
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BENEFITS AND PAYArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra Arsenal Days of Rest every quarter for employees to recharge. Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.We have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as 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.We are committed to hiring the best talent from diverse backgrounds. 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.The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $169,000-$207,000. Salary ranges for other locations may vary. Base pay offered may vary based on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.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.Candidate Privacy Policy