Upstream Scientist I, Manufacturing Sciences & TechnologyRequisition ID:
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific Information
This role is supporting our Viral Vector Services facility in Cambridge, MA. How will you make an impact?
The primary responsibility is to be part of technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, Process Development, Engineering, Supply Chain and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient upstream manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.
Scientist I in MST will work closely with the Upstream, Downstream, Analytical and DP MST groups as well as clients and the Commercial team to support client projects and with VVS Florida site, PD, Quality, EHS, and Manufacturing to ensure compliance and technology transfer. Additionally, based on project assignment the role designs and executes process characterization projects for VVS.What will you do?
How will you get here?
- Participates in cross functional technology transfer teams for cGMP DS manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Includes authoring of upstream plan documentation and associated PDPRs.
- Represent Upstream on client programs as assigned. Execute MST process establishment runs, ensuring the materials, strategy and documentation are as needed.
- Execute Upstream laboratory work, implement and analyze aimed at understanding, improving, and transferring upstream MFG processes and technologies. Maintains a good laboratory practice.
- Maintain an accurate schedule/project plan of assigned MST lab work and deliverables.
- Author protocols and reports related to MST Process Establishment, PC, PPQ as assigned.
- Monitor and trend process performance, including input and output parameters.
- Support investigation root causes of deviations for cGMP manufacturing, and implement CAPA
- Identifying opportunities to improve systems and practices
- Work with Upstream counterparts in VVS Alachua Process Development and Cambridge Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
- Bachelor or advanced degree in Biochemical, Chemical Engineering, Biomedical Engineering or a related scientific discipline such as Chemistry or Biology.
Knowledge, Skills, Abilities
- B.S. with 3+ years' experience, or Master's degree with 1+ years' experience, or PhD.
- Strong interpersonal and communications skills; written and oral.
- Ability to work both independently and as part of a team.
- Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
- Experience performing process characterization studies highly desirable
- Knowledge of cGMP requirements
- Knowledge of cell and gene therapy vector production highly desirable.
- Ability to be hands-on
While performing the duties of this job, the employee:
- Ability to function in a rapidly changing environment & handle multiple priorities.
- A flexible work schedule is required.
- Ability to lift up to 25 lbs.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has 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.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.