Scientist II, Upstream or Downstream Process Development ( on site)

Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionLocation/Division Specific Information : US - Massachusetts – Plainville (on-site)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 cutting-edge 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 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.What will you do?

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.

EducationB.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 andscaling 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 neededAt Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.