Scientist II Process Development - Downstream

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.  At Viral Vector Services (VVS) a division of Thermo Fisher Scientific, we deliver from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and Cell and Gene Therapy business, our mission is to enable clients to cure genetic, rare, and otherwise untreatable diseases.  How will you make an impact?  As the Downstream Process Development Scientist you will help our clients to deliver lifesaving and life changing therapies to patients. You will planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will also act as a subject matter expert (SME) and support a detailed transfer and operation of internally developed and client-transferred processes into the process development. You will also be supporting tech transfer out to the cGMP manufacturing space.    What will you do         -Contribute to multiple projects and participate in the planning and execution of process development and scale up activities (both bench and pilot scale).  -Serve as functional SME and work collaboratively with other team members on all aspects of upstream or downstream execution for viral vector processes.    -Participate and/or own the training and development of other team members.  -Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports).  -Identify technical gaps/facility fit challenges for new clients/processes  Support analytical testing for process development and characterization.  How will you get here  Education  B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs, of experience or Master’s degree.  General qualifications:   -Demonstrate understanding of experimental design with the ability to independently conduct laboratory experiments.  -Collaborate with the Analytical Development team to develop comprehensive testing plans.  -Participate in client meetings to present results and assist with drafting process development reports.  -Independently prepare or review Process Development records, work instructions, and batch records.  -Design and conduct Design of Experiments (DOE) studies and high-throughput screenings tailored for either upstream or downstream process development.  -Proficiency in technical writing, adhering to Good Documentation Practices (GDP), with preferred experience in data compilation and interpretation.  -Flexibility in work hours, including availability for weekends and evenings to meet project timelines.  Downstream Process Development Qualifications:   -Expertise in various purification techniques, including affinity and anion exchange chromatography, with proficiency in using AKTA chromatography systems and Unicorn software.  -Extensive experience with filtration-based unit operations such as tangential flow filtration, sterile filtration, and depth filtration.  -Familiarity with viral clearance processes.  Knowledge, Skills, Abilities  -Working level knowledge of downstream purification of mammalian