Process Engineer III, Tech Transfers

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future!

EDUCATION

• Bachelors Of Science Degree required in the life sciences, engineering, or equivalent technical field
• 4+ years of experience with BS Degree 2+ years experience with MS Degree 1+ years of experience with PhD

EXPERIENCE

• Manufacturing technical support experience in a Viral Vector, Biologics, or vaccine production
• A sound understanding of viral vector production and analytics, scale-up principles, process validation, and regulatory strategies.
• Experience in research & development or manufacturing a plus.
• Expertise and ownership of complex process/product impacting investigations

KNOWLEDGE, SKILLS, ABILITIES

• Highly developed project management skills with the ability to elicit partnership from a wide variety of departments
• Strong documentation practices and attention to detail
• Proficient in Microsoft Office program suite
• Strong decision-making and problem solving skills
• Ability to prioritize and execute tasks in a multifaceted environment
• Familiarity with following software packages a plus: Visio, JMP, and MS Project
• Knowledge of FDA, EMA, and other relevant regulatory environments is a plus.
  At Thermo Fisher Scientific, each one of our 70,000 outstanding minds has a unique story to tell. Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer.
  We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

• Provide leadership on technical strategy and execution from project initiation through scale up and tech transfer.
• Attend and/or lead internal and client project meetings
• Perform technical review for internal and client project documents (tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports).
• Provide technical assessment on project change controls and deviations
• Perform equivalency assessments/gap analyses during tech transfer activities and sourcing/designing materials or equipment as needed
• Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
• Provide on-the-floor technical and scientific support for critical manufacturing operations ·
• HOW WILL YOU GET HERE?Technical expertise in a fast-paced and highly technical environment at the cutting edge of gene therapy manufacturing. Driving projects to meet aggressive first-to-market clinical/commercialization timelines while defining standards and driving improvements