Job Title: Associate II Drug Product Manufacturing

Requisition ID:

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. 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

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 Drug Product 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. Assist with the on-time closure of Nonconformance’s/ CAPAs, as needed. Additionally, this position will lead Practical Process Improvement (PPI) initiatives and continuous improvements. Ensure tasks are executed with a method of prioritization ‐ interpret production schedules and complete tasks accordingly. Actively provide feedback and escalate issue or take action and provide resolution as appropriate. e.g. issuing work notifications or collaborating with other departments to provide closure. Active participant of performance huddles and assisting Supervisors to plan out and populate process schedules. This will apply to the below task breakdown:

Drug Product GMP Production (85% of time spent on floor)

• Fully trained on all unit operations associated with their department (ex. formulation, sterile filtration, aseptic filling, etc.).
• Viewed as an SME/expert in at least one unit operation.
• Provide critical evaluation of processes, including foresight and thinking ahead.
• Act as a guide to new employees during onboarding process.
• Responsible for the upkeep of manufacturing equipment and maintaining an up to date skills matrix.
• Conduct drug product (Fill/Finish) 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.
• 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, Downstream, Support Operations) tasks and related production processes, when required.

Prepare and Review Documents (10%)

• Review, revise, and author manufacturing batch records.
• Complete preventative maintenance and work notifications tasks on time.
• Collaborate with quality and PD to review and signoff on executed batch records.
• Own the executed batch record reconciliation and other production related documents.
• Working with Drug Product Supervisors to review, revise, and author Work Instructions (WI)/SOPs/Material Specifications (SPEC).

Process Development and Improvement (5%)

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

Education/Experience

• High School Diploma / minimum 2+ years of relevant experience or superior demonstration of skill sets or background
• Preferred Bachelor’s Degree in related field

Knowledge, Skills, Abilities

• Intermediate understanding of Drug Product manufacturing and general Good Manufacturing Practices (cGMP).
• Excellent communication skills.
• Desired proficiency in Microsoft Word, Excel, PowerPoint, etc.

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.