Job Title: Associate II Downstream Manufacturing

Requisition 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

Alachua, FL – Viral Vector Services Division

How will you make an impact?

The Associate II position will support cGMP manufacturing activities to ensure that Thermo Fisher Scientific Viral Vector Services provides clients with gene therapy products for pre-clinical and clinical use. This position will perform hands on cGMP production of recombinant protein and viral vectors under the supervision of the Downstream Manufacturing Leadership.

What will you do?

The Associate II will maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensuring MFG chemicals are properly stored and labeled. This position will adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Ensuring documentation of all activities meet cGMP requirements. Assisting with the on‑time closure of Events/CAPAs, as needed. Additionally, this position will assist in the completion and identification of Practical Process Improvements (PPI) initiatives and continuous improvements. Contribute to daily huddle, actively provide feedback and escalate issue or take action as appropriate, active participant of performance huddles and assisting Supervisors to plan out and populate process schedules. This will apply to the below task breakdown:

Downstream GMP Production (90% of time spent on floor)

• Conduct downstream production suite preparation and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records.
• Able to assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Fully trained on all unit operations associated with their department (ex. column chromatography, TFF, filtration, ultracentrifugation).
• Act the lead technician in the independent execution of unit operations.
• Performs equipment testing and routine trouble‐shooting and maintain an up to date skills matrix.
• Support and conduct other sub-team (Upstream, Fill Finish, Support Operations) tasks and related production processes, when required.

Prepare and Review Documents (5%)

• Assist with batch record reconciliation. Complete preventative maintenance and work notifications tasks on time.
• Working with Downstream managers, assist in drafting process procedures including SOPs, PBRs, RMS etc. for new processes or equipment. Assist in sourcing cGMP compatible equipment and raw materials. Assist in the execution and review of IQ, OQ and PQ protocols.
• Draft deviations reports, as required.
• Review executed Production Batch Records (PBR), and other production related documents.

Process Development and Improvement (5%)

• Assist Downstream Manufacturing Manager/supervisor in the development or optimization for downstream processes for manufacturing.
• Assist in the technical transfer of processes from Process Development laboratories to manufacturing.

How will you get here?

Education/Experience

• High School Diploma / minimum 1+ years of relevant experience or superior demonstration of skill sets or background
• Bachelor’s Degree in related field / 0+ years of relevant experience

Knowledge, Skills, Abilities

• Basic/Intermediate understanding of downstream processing methods (Chromatography, TFF, Nanofiltration, Ultracentrifugation, detergent treatment, sterilizing grade filtration).
• Excellent communication skills.

Working Hours/Overtime

• This position will start as a fulltime, Mon – Fri, 40-hour work week
• Expected within approximately 6 – 12 months to transition 12-hour shifts.
• Overtime and weekend work will be required as needed.

At Thermo Fisher Scientific, each one of our 75,000 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.