Scientist 1 Downstream Manufacturing
Job Title: Scientist 1, Manufacturing Downstream
Requisition ID: 194666BR
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
Alachua, FL – Viral Vector Services Division
How will you make an impact?
The Scientist 1 position will support cGMP Downstream Manufacturing (DSMFG) activities to ensure that Thermo Fisher Scientific Viral Vector Services provides clients with gene therapy products for pre-clinical and clinical use. You will be assigned client projects to perform hands on cGMP manufacturing and process development production of recombinant protein and viral vectors under the supervision of the DSMFG leadership. You will also serve as primary or secondary lead for your projects to interact daily/weekly with external clients and interface between Process Development (PD), Manufacturing Sciences (MST), and the immediate Downstream Manufacturing Associate teams to ensure project readiness for Downstream cGMP manufacturing production.
What will you do?
Production in the Manufacturing Facility and Process Development Labs (45%)
- Act as lead technician for your projects on the DSMFG floor and provide guidance to other technicians while following detailed protocols, batch records and SOPs, to complete production runs in an efficient, safe, and correct manner.
- Work with your PD project lead counterpart to assist in PD runs and learn the process before transfer to MFG. At a minimum, you are required to be present in the PD labs for the last PD run before process transfer to MFG.
- Designing and process engineering for new processes/equipment may be required for your projects.
- Request necessary DSMFG raw materials, components, buffers, and production documents to successfully execute manufacturing production runs.
- Assist with DSMFG supervisors and manager in scheduling, organizing, and coordinating DSMFG activity efforts in production suites for your projects.
- Maintain a culture of safety by identification of near misses, safety walkthroughs, and assisting with resolution of safety observations.
- Ensure chemical waste streams are followed for your projects (proper storage, labelling, and disposal of chemicals and buffers).
Technical Writing and Review (25%)
- Write process procedures including batch records (BR), standard operating procedures (SOP), Work instructions (WIs), and chemical waste streams.
- Drive the completion of new material specifications and/or purchase of new equipment for your client projects. Assist the Facilities department with installation and qualification (IOQ) of new equipment where applicable.
- Work with the Manufacturing Compliance team to draft Change Controls (CCs), Planned Variances (PVs), Deviations and Investigation Reports relevant to your projects.
- Review executed BRs on the floor and after batch completion.
- Assist MST with the completion of Detailed Process Descriptions (DPD) and technical transfer documents.
Interdepartmental and Client Communication (25%)
- Interface directly with client and other project leads on weekly client facing meetings as a DSMFG lead (or backup).
- Communicate with PD and MST project lead counterparts about run planning and process transfer.
- Work with Supply Chain/Material Planning team to complete working bill of materials (wBOM) for your projects.
- Coordinate with Facilities department for any new equipment receipt and installation for your projects.
- Work with and provide updates to your DSMFG lead or backup for your projects daily.
- Escalate to manager immediately any deviations or challenges that may or may not have product impact for efficient resolution.
Other Duties as Assigned (5%)
- Lead PPI initiatives and continuous improvements.
- Assist the Downstream Manufacturing Leadership in development or optimization of downstream processes for manufacturing
How will you get here?
High School Diploma / 5+ years of relevant experience or superior demonstration of skill sets or background
Bachelor’s Degree in related field / 2+ years of relevant experience or superior demonstration of skill sets or background
- Experience in a cGMP production facility and testing environment.
- One year of appropriate experience in same or related fields.
Knowledge, Skills, Abilities
- Basic understanding of downstream processing methods (column chromatography, TFF, nanofiltration, ultracentrifugation, detergent treatment, sterilizing grade filtration).
- Excellent communication skills and technical writing.
- This position is normally fulltime, Mon – Fri (8hr shifts).
- Overtime, weekend work, and late shifts will be required depending on the client project and production schedule. Flexibility is a must.
At Thermo Fisher Scientific, each one of our 85,000 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.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.