Biomanufacturing Process Development Manager

POSITION SUMMARY:

The Nonhuman Primate Reagent Resource (NHPRR) under Diogo Magnani of the UMass Chan Medical School is looking for a full-time team manager to support the mission and establishment of a new preclinical biomanufacturing production core.  NHPRR is a vibrant research and product development environment with close links to top academic, nonprofit, and industrial institutions worldwide. NHPRR is the premier research group developing and manufacturing antibodies specifically designed for studies with nonhuman primate models of human disease.

The successful candidate will join a growing resource with 25 years of experience, delivering products to 1000 research laboratories, representing 22 countries, and supporting over 3,600 grants. The Biomanufacturing Process Development Manager will bring critical specific expertise in developing and executing biomanufacturing production processes for primate antibodies. The ideal candidate will hire, train, and manage a team of five operating a biomanufacturing service that covers processes in cell line development, bioreactor operations (1L, 1L, 20L to 100L scales), downstream purification, analytics, quality studies, and reporting. Additionally, the successful candidate will conduct and oversee the operation excellence, and report to the Program Manager, Director, Clients, and UMass Chan leadership.  

ESSENTIAL FUNCTIONS:

• Oversees the work of a team of research associates. Includes coordinating, assigning, and prioritizing day-to-day work, overseeing the quality, budget, and progress of work, providing updates and insight to External Interactions teams, leading operational improvements with the Operations team, and interacting with the Software Engineering team to improve laboratory tools.
• Executes day-to-day operations of producing biologicals. This includes vigorous lab process control and quality monitoring, and a persistent focus on strict lab practices to minimize sample mishandling and contamination.
• Supervises the workflow of product manufacturing. Includes performing the workflow, organizing and coordinating the weekly work, executing appropriate QC steps before delivering data to external collaborators, and collaborating with scientific leadership
• Responsible for interfacing with collaborators on reagent-type requests, appropriately triaging to the in-lab team, and communicating with the External Interactions team to appropriately prioritize the requests and offer guidance to collaborators.
• Adapts well to the ever-changing platform needs in workflows, projects and staffing structure.
• Develops platform processes and technologies.
• Designs experiments, analyzes data, and draws conclusions.
• Develops, optimizes, characterizes and troubleshoots cell culture processes to produce mAbs, gene therapy vectors, and other biologics.
• Designs, performs and analyzes small-scale cell culture experiments. Develops new cell culture growth and feed media formulations.
• Analyze data by statistical, Design of Experiment (DoE), and graphical procedures in order to provide accurate, concise and pertinent summaries and data reports.
• Collaborates with other groups within Process Development and the organization to meet organizational objectives.
• Transfers processes to supports large-scale manufacturing at up to 250L scale (preclinical and cGMP)
• Ensures that all work is properly documented according to phase-appropriate analyses, and suitable for regulatory submission.
• Drafts technical reports to support technology transfer, regulatory and intellectual property submissions.
• Maintains substantial knowledge of state-of-the-art principles in cell culture technology.
• Other tasks as required by the platform and platform development. May perform other duties as assigned.

REQUIRED QUALIFICATIONS:

• Bachelor's Degree in Biology is required
• 5+ years hands-on and team experience in process development for large-scale manufacture of primate biologicals.
• 5+ years of direct pharmaceutical process experience
• 1-2 years of management of teams or workflows or associated operational experience, direct experience managing a team is preferable 
• Demonstrated ability to plan customer project requirements and timelines
• Analytical Laboratory experience, specifically addressing upstream process development and/or large molecule characterization applications in pharmaceutic drug development to help customers accelerate their process.
• In-depth understanding of what Process Development Scientists, Analytical Scientists, and their leadership team need to solve in drug discovery and development.
• Proven success in identifying and executing process development optimization projects.
• Comfort in using and development rigorous electronic lab documentation systems to support the development of a good lab practice (GLP) quality system.
• Customer orientation to develop partner support.
• Ability to take on new skills and techniques quickly and think critically 
• Excellent interpersonal, organizational, problem solving, and decision making skills with strong attention to detail
• High level of initiative and the ability to work with little supervision, proactively addressing issues as needed
• Ability to participate in and foster a strong team environment while also interfacing and bridging with various other platform members such as project and operations managers, software engineers, and lab biologists 
• Demonstrated ability in keeping teams, projects, and deliverables on track while being flexible to shifting priorities 
• Operate and maintains automated laboratory equipment to complete investigations
• Prepare, order, and maintain stocks of necessary reagents, solutions and supplies (i.e. coordinates production supply chain)
• Help to train new lab members, students, interns, and collaborators
• Attend team meetings to share results, plan projects and experiments, ensure that projects support current team goals in a dynamic environment