Director, Process Engineering (25105-R-680-PS) - ArsenalBio
View Company Profile- Job Title
- Director, Process Engineering (25105-R-680-PS)
- Job Location
- Hayward
- Job Description
- WHO WE AREArsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Director, Process Engineering 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.ArsenalBio is seeking a driven and experienced Director to join the ArsenalBio Technical Operations team (on-site position at our Hayward, CA location). 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.The individual will lead the Process Engineering team and serve as the liaison between Process Development and Manufacturing to lead the technology transfer, process comparability studies and qualification/validation activities for ArsenalBio’s cell manufacturing processes. Responsibilities will include facilitating manufacturing investigations, monitoring manufacturing process performance and establishing raw material qualification strategy for critical process materials. The ideal candidate has experience in late stage process development for cell therapy products and will lead process characterization and validation efforts to support pivotal trial/BLA readiness.WHAT YOU’LL DO
- Lead the characterization and validation efforts for drug substance and drug product manufacturing process
- Develop and support implementation of a CMC process development strategy to enable successful regulatory submission and approvals in collaboration with Process Development and Manufacturing
- Identify and control process risks, using quality tools and process instructions & design in collaboration with process development and manufacturing teams
- Continue to build process monitoring and trending program in collaboration with Manufacturing
- Lead technology transfer activities, including process description, comparability protocols and generation of risk assessments
- Develop and implement phase appropriate strategies for efficient transfers and verification/validation/comparability execution
- Support regulatory filings, site readiness, and facility startup as needed.
- Identify root cause and provide impact assessments (including technical assessment for supplier initiated changes) to maintain routine manufacturing operations and determine process improvements.
- Author and review CMC regulatory sections, technical reports and source documentation supporting regulatory submissions
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 Process Engineering, Process Development or Manufacturing
- Demonstrated track record of successfully developing and transferring cell therapy manufacturing processes
- Practical knowledge of cGMP application and aseptic/sterile technique in ISO 7/Grade B and ISO 5/Grade A environments in the cell therapy space
- Strong desire for experience in startup/qualification of facility and process, adapting and thriving in a rapidly changing and fast-moving environment.
- Strong grasp of statistical approaches for design of experiments (DoE) process characterization, process comparability, and data analysis
- Ability to understand and troubleshoot manufacturing process and equipment and author/review/approve associated GMP documentation
- Experience in clinical scale cell processing, process closure, harvest/fill/finish, cryopreservation and automation desired
- Knowledge of regulatory and quality requirements and experience working in a regulatory environment (FDA, EMEA, and others) is essential.
- Excellent written and verbal communication and collaboration skills
- Proven track record of mentoring/coaching junior team members
Preferred Qualifications- Experience with process qualification/validation for late-stage clinical/BLA readiness/commercial settings is highly desirable
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ArsenalBio Company Size
Between 100 - 500 employees
ArsenalBio Founded Year
2019
ArsenalBio Total Amount Raised
$630,806,656
ArsenalBio Funding Rounds
View funding detailsSeries C
$325,000,000 USD
Series B
$220,806,682 USD
Series A
$85,000,000 USD