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 Leader of Manufacturing for process development and manufacturing of cell therapy products. You will have extensive direct experience in process development, the establishment of cGMP processes, manufacture and release of cell therapy products, as well as the design and management of cGMP facilities.
What You Will DoLead all elements of technical operations, process development, manufacturing, and supply chain resources to develop a scalable, cGMP-compliant process to manufacture cell therapy products to support preclinical and clinical studiesDrive accountability by creating and articulating a clear plan of action aligned to the corporate and program objectives, guide daily activities of the team, and provide ongoing feedback at an individual and team level.Oversee the selection and management of any Contract Manufacturing Organizations (CMOs) and all external partners to ensure competence, data integrity, and adequate supply of critical materialsCollaborate closely with other functions to ensure successful program development; encourage cross-functional collaboration with peers to overcome challengesResponsible for developing and managing timelines and ensuring development and tech transfer of processes occur in a timely mannerResponsible for establishing the necessary SOPs, batch records, reports, and IND sections for clinical translation and development of the cell and gene therapy platformsOrganize, communicate, and present complex data sets to senior management and key stakeholders
What You Will Bring:BS or equivalent degree in bioprocessing, medical technology, chemical engineering, or biological sciences is required. Advance degree preferred 10 plus years of experience in academia, biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products8 plus years of increasing responsibility in managing and leading a team of process development engineers and manufacturing teamsExperience with the set-up, technology transfer and execution of manufacturing processes and controls internally or at CMOsExperience with the direct manufacture of cell therapy products and/or management of technology transfer and subsequent manufacture of cell therapy products at CMOsExperience preparing documentation for regulatory filings with US and EU regulatory agenciesDemonstrated technical and strategic leadership and problem-solving skillsAbility to work independently and as part of a team with exceptional ability to collaborate and leadExperience presenting complex concepts to all levels of the organization, with proven ability to clearly articulate a point of view and recommendationAbility to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values (fearless, accountable, collaborative)Expertise influencing across functions and teams to achieve organizational objectivesExpertise in staffing, budgeting and expense managementProven project management capability with a track record of meeting timelines is requiredExcellent written and oral communication skills to influence effectively across the organization and with CMOs
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.