Thermo Fisher Scientific Lead Scientist, Process Sciences in Cambridge, Massachusetts
How will you make an impact?
The Lead Scientist will manage planning, execution, and external customer interactions for process establishment, late phase development, process characterization, and process validation, for multiple, simultaneous client viral vector cell and gene therapy programs. He/She will work closely with colleagues in the Process Sciences (PS) team, MST, PD, Quality, EHS, Commercial, and Manufacturing to ensure compliance and successful technology transfers. This position will interface directly with external clients to provide scientific expertise and process guidance.
What will you do?
Support technology transfer teams for process establishment of viral vector manufacturing processes.
Lead and manage process establishment, pilot and process characterization studies ensuring the materials, strategy and documentation are defined as needed.
Execute laboratory work including design, implementation and analysis aimed at understanding, improving, and transferring manufacturing processes and technologies.
Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.
Represent PS on CMC teams and sub-teams as a Technical Project Lead to coordinate multi-functional activities for late-phase clinical programs.
Maintain an accurate schedule/project plan of assigned PS lab work and deliverables.
Manage preparation and review of necessary technical documentation
Author and maintain process risk assessment and Failure Mode and Effect Analysis documents
Identify opportunities to technically and operationally improve systems, practices, and technologies
Collaborate with other Thermo Fisher Scientific sites and clients to ensure success of scale-up and process transfer.
How will you get here?
PhD in the Life Sciences, Engineering, or related field, with 2+ years' experience. Equivalent combination of degree and experience may be considered.
Technical expertise in upstream and/or downstream biopharmaceutical process development and/or manufacturing.
Desired Upstream Experience Includes: Adherent and suspension mammalian (HeLa, HEK, Vero) and insect (Sf9) cell culture. Knowledge of Stirred Tank Bioreactors (fed-batch and perfusion), flat stock technology including Cellstacks, Hyperstacks and iCellis. Viral vector production platforms including transient transfection, stable producing cell lines, and helper virus technology. Perfusion technology including ATF and hollow fiber TFF.
Desired Downstream Experience Includes: Filtration (dead end and tangential flow) and process considerations for scale up. Experience with various chromatography resins and membranes. Ability to operate various AKTA and other chromatography systems.
Matrix leadership experience.
Experience in late stage/commercial technology transfer and process validation for biologics manufacturing
Knowledge, Skills, Abilities
Demonstrated trouble shooting and problem-solving skills.
Strong interpersonal and communications skills; written and oral. Ability to speak effectively before clients.
Ability to work both independently and as part of a team.
Ability to function in a fast-paced dynamic team environment and balance priorities across multiple projects
Knowledge of statistical analysis methodology and software (JMP or equivalent) is highly desired.
Working knowledge of cGMP and regulatory requirements of biopharmaceutical manufacturing.
Knowledge of cell and gene therapy vector production highly desired.
Project management skills desirable.
Ability to be hands-on.
Ability to function in a rapidly changing environment & handle multiple priorities.
A flexible work schedule is required including Weekend and night as needed to support lab activities.
Ability to lift up to 25 lbs.
At 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.
Apply today! http://jobs.thermofisher.com
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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