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.
We are seeking a talented and motivated Manager to join the ArsenalBio Process Development and Technology Operations (PDTO) team to establish and perform Quality review and oversee functions at Contract and Development Manufacturing Organizations (CDMOs) and Contract Testing Labs (CTLs). The individual will support ArsenalBio’s manufacturing process for clinical trial material production, testing, release of clinical material, and be instrumental in developing the framework of product quality oversight and infrastructure. The individual will work closely with team members to develop Quality infrastructure. The position will report to the Director of Process Development and Technology Operations. The individual will also interact cross-functionally across the organization to enable ArsenalBio’s success.
What You Will DoManage and review batch records, protocols, lot release testing, stability, clinical handling studies, and method validations studies performed at external vendors and coordinate with internal groupsSet ArsenalBio’s quality expectations and manage the CMO Quality infrastructure and release process (e.g. SOPs, batch records, specifications approval) necessary for the oversight of ArsenalBio’s external supply chainSupport development of stability programs and specifications including a proposal of product-specific analytics and acceptance criteria justificationsPartner with PDTO in the transfer of manufacturing process and analytical methods to ArsenalBio’s CDMO and CTLsWork with direct line management to identify areas of process improvements and contribute to the development of new concepts, techniques, and standardsCollaborate with PDTO to manage assay lifecycle, create assay and process capability trending programs, and define system suitability criteriaRepresent Quality on project teams and in other cross-functional programsCreate and manage programs for the characterization and qualification of reference materials, assay controls, QC cell banks, and critical reagentsResolve contract laboratory and contract manufacturing deviations, OOS/OOT and lab investigations, CAPAs, and product-related change controlsReview and approve Quality SOPs, policies, batch records, analytical test methods, protocols, and reports, as neededSupport Quality audits and technical visits
What You Will BringMS or BS in relevant scientific field or discipline, 6+ years experience (3+ years experience in a management function) and strong scientific background in Quality Control and Quality Assurance in the drug development industry with strong knowledge of cGMP/ICH/FDA/EMA regulationsPrior experience in Quality Assurance for cell therapy products as well as oversight of Quality at contract organizations highly preferredSuccessful experience writing and reviewing SOPs and other Quality documentsDirect experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, document control, etc.)Team player with the ability to work in a collaborative, fast-paced team environmentStrong written and verbal communication skills and experience with working in cross-functional teamsStrong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutionsExcellent problem-solving skills and experience with root cause investigations and CAPA determinationAbility to lead successfully within extended project teams and handle multiple challenges under pressureExcellent communications and presentation skills, written and verbalExcellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneouslyWillingness to travel
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.