ROLE SUMMARY
? The qualified candidate will join the Manufacturing Science and Technology (MSAT) organization supporting biological therapeutics and vaccines. Within MSAT, the candidate will work in the Purification Group, which develops processes for isolation and purification of recombinant proteins, polysaccharides, bioconjugates, and other biologics.
? Projects may include execution of processes at lab and pilot scales, process development and characterization, scale-up and tech transfer to commercial manufacturing, process simulation and modeling, process troubleshooting, new technology development and implementation.
? The incumbent will run various recovery and purification unit operations, including preparative chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) at lab and pilot scales, as well as providing support for commercial scale operations as needed.
? The scope of the project work may include tasks in any or all of the following stages: scope definition, feasibility studies, cost/benefit analyses, design, specification development, project planning, implementation, and post-implementation monitoring and follow-up.
? The incumbent must be capable of providing significant contributions to cross-functional projects and may lead some teams with involvement and coaching from their supervisor.
ROLE RESPONSIBILITIES
? Utilizing a high level of technical expertise, the incumbent is responsible for moderately complex projects related to the development, scale-up and/or characterization of processes, equipment, and control strategies, process optimization, qualification of alternate raw materials and components, and/or technology transfer to GMP commercial manufacturing facilities.
? The candidate must be able to execute, analyze, document, and communicate results from experimental studies conducted at lab, pilot or commercial scales. The candidate must be able to interpret data and make recommendations to optimize processes, improve yields, and enhance the smooth transition from development through to successful implementation.
? The incumbent will be responsible for troubleshooting and resolving process issues, diagnosing technical problems, and determining short and long term solutions. The incumbent will be required to work both independently and in team environments and be able to coordinate multiple technical projects simultaneously in a well-organized fashion.
? The incumbent will be expected to prepare technical reports, provide oral presentations to scientists and management, and assist in the preparation of regulatory filing documents, as required.
QUALIFICATIONS
Degree in Chemical/Biochemical Engineering, Biochemistry, or other related biotechnology discipline: Ph.D. degree; M.S. degree with a minimum of 2 years of relevant experience; B.S. degree with a minimum of 4 years of relevant experience.
? Technical knowledge and skills in purification of biologics achieved through industrial or academic experience in research and development, technical operations, manufacturing, etc.
? Experience with operating, monitoring and/or control of purification processes including Chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF).
PHYSICAL/MENTAL REQUIREMENTS
Able to lift moderate weight
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work with potentially hazardous chemicals using appropriate personal protective safety equipment in a properly controlled environment