As a member of the MSAT Team, responsible for the successful transfer of viral vector bioprocesses into GMP production. As such, you are in direct contact with our clients and internal cross functional teams. Scientist III will ensure successful process scalability and manufacturability. Scientists in this role are responsible for all the process integration-related aspects of work during campaign preparation, process supervision, reporting during and after production campaigns, leading relevant major deviations and continuing manufacturing process improvement under the supervision of a Sr. Scientist and/or Manager. Please note that we are unable to sponsor applicants requiring work authorization or visas for the positions currently available. We kindly request that only candidates who already possess the legal right to work in the United States apply for consideration.
RESPONSIBILITIES: • This individual will utilize the process flow diagrams, learned expertise, and transferred data to transfer detailed, step-by-step manufacturing processes under the supervision of a senior MSAT scientist and/ or manager of MSAT. • This position has responsibilities that can be exemplified by the technology transfer of all aspects of buffer and media production, cell thaw and culturing, harvesting, purification, and/or bulk filling of drug substance. • This person will perform portions of process transfer from either PD Lonza or from customers. This individual will do this commensurate with their experience and under GMP conditions. This person will utilize project and time management skills to ensure that all tasks will be completed within a timely manner, and that risks to project execution are raised in a timely manner to senior engineer(s), project management, and / or MSAT management as appropriate. • The position will support new product introductions (NPI/ technology transfers) with minimized assistance from the senior engineer associated with a project, as well as ongoing manufacturing runs by correcting errors noted in previous runs, observing processing on-the-floor (under the supervision of a senior scientist), and overseeing operations within their area of subject matter knowledge to assure planned, predictable operations, as well as to correct if the operations are not performing as anticipated by the manufacturing records. • The individual gains mastery of various unit operations, the science behind it, and associated process analysis techniques, and applies them, and continues the journey from individual contributor to subject matter expert in either upstream or downstream processing. This individual will pursue successful resolution of complex quality system deviations from expected results, driving for holistic and/or targeted solutions to ensure process and product quality and the smooth, on-time delivery of batches to our clientele, looking for overall improvement in systems and processes each time. • This position is likely to participate in more complex tasks such as the technology transfer and oversight, as well as process improvements, for all process steps, under reduced supervision of the senior MSAT scientist associated with the project. • This person may assist in the creation of a full bill of materials for a given program, likely performing materials suitability assessments for appropriate alternatives / second sources for materials needed in conjunction with a junior engineer who is more likely to take the greater part of this activity.