Scientist II, Upstream or Downstream Process Development
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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 sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
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 cutting-edge Cell and Gene Therapy business, our mission is to enable clients to cure genetic, rare, and otherwise untreatable diseases.
Scientist II, Upstream or Downstream Process Development (on site)
As either the Upstream or Downstream Process Development Scientist II you will help our clients to deliver lifesaving and life changing therapies to patients in need. You will be responsible for planning, executing, and detailing 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 flawless transfer and operation of internally developed and client-transferred processes into the process development and pilot space. You will also be supporting tech transfer out to the cGMP manufacturing space.
Responsibilities
- Contribute to process development and scale-up projects.
- Act as a subject matter expert in upstream or downstream processes for viral vectors.
- Lead training activities.
- Prepare and modify development documents and reports.
- Identify technical challenges and solutions for new processes.
- Support analytical testing and data interpretation.
Qualifications
Education
- B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs, of experience or Master’s degree.
General qualifications
- Proven understanding of experimental design and 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.
- Strong communication skills with the ability to clearly and concisely interpret, summarize, and present scientific data.
- Flexibility in work hours, including availability for weekends and evenings, as the need arises to meet project deadlines.
Upstream Process Development Qualifications:
- Practical experience in aseptic techniques, cell culture, single-use bioreactors (SUBs), wave reactors, and harvest/clarification processes.
- Familiarity with transfection and infection -based processes for gene therapy production
- Expertise in working with single use stirred tank bioreactors
- Experience in scaling up and scaling down upstream processes for viral vectors or biologics.
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.
- Experience in scaling up and scaling down downstream processes for viral vectors or biologics.
Knowledge, Skills, Abilities
- Ability to analyze and summarize scientific data
- Understanding of GLP requirements of biopharmaceutical development.
- Strong interpersonal and communications skills; written and oral
- Ability to function in a constantly evolving environment & prioritize multiple priorities.
- A flexible work schedule is required including weekend and night as needed to support lab activities.
** You may be required to support other VVS MA sites as needed
Environmental Conditions
Office
Work Schedule
Other
Apply today! http://jobs.thermofisher.com
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
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