Job Description
This role supports tactical operational activities associated with contract development manufacturing organizations (CDMOs) and manufacturing partners developing, producing and/or testing company products, reagents and intermediates. This role:
Supports the primary point of contact for all activities occurring at CDMO including, manufacturing, planning, supply chain, quality, testing, regulatory, inspections, projects, and business relationship with the CDMO.Observes on-the-floor manufacturing activities, manufacturing and validation readiness activities, championing of deviation investigations, corrective/preventative action implementation, and change control management, as well as support for regulatory inspections.Focus on CDMO performance to manufacturing process, cGMP and regulatory requirements. Reports observations to CDMO leads and works closely with the CDMO to ensure information is shared to help improve the process and CDMO performance,Proactively provides scientific and hands-on support and troubleshooting for all aspects of technology transfer, process scale-up, process monitoring, manufacturing, QC testing, packaging and logistics activities.Fosters cross-functional working relationships with internal and external groups to ensure successful development and delivery of all products.Requirements:Bachelors in a biological science with 5+ years of relevant experience in biologics development including cell therapy development.Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems and regulatory requirements.Demonstrated track record of effective leadership and partnership in a contract manufacturing setting.Clear and concise communicator who is a team player and a proven negotiator.Expert problem-solver that leads with data, seeks subject matter expertise and is considerate of others point-of-view.Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.Effective interpersonal skills as both a team leader and a team player.Strong leadership presence with ability to garner respect through sound technical analysis, business judgment and clear decision-making.Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive decisions among individuals from a variety of cultures and disciplines.Role model for TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
