Scientist I, Manufacturing Fill Finish

*Job Title: Scientist I, Drug Product Manufacturing
Jo**b ID: 166156BR*

Viral Vector Services (VVS), a division of Thermo Fisher Scientific is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy technologies, we enable clients to cure rare genetic and otherwise untreatable diseases. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
*Location/Division Specific Information*
Alachua, FL - Viral Vector Services Division, Part of Patheon
*How will you make an impact as a Scientist?*
You 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 provide expertise and perform hands on cGMP production of recombinant protein and viral vectors.
*What will you do as a Scientist? *
The *Scientist I* will maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations, and ensures 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. Core responsibilities include but are not limited to:
Drug Product PD and GMP Production (40% of time spent on floor)

* Provides leadership and oversite for Phase I/III fill/finish operations (formulation, aseptic sampling, sterile filtration, filling, inspection, and labeling) and ensures cGMP procedures are maintained and followed.
* Practices and promotes safe work habits and adheres to safety procedures and guidelines.
* Understands aseptic processing, environmental controls and semi-automated filling systems. Understands inspection of finished product, labeling and vial reconciliation requirements.
* Performs batch record review, procedure revisions, and work order generation.
* Performs training with staff on the floor, supports equipment calibrations and preventative maintenance, documentation, investigations and improvement initiatives within manufacturing operations.
* Recognizes and celebrates successes.
* Utilizes manufacturing processes knowledge and investigational skills to identify and resolve manufacturing issues and drives continuous improvement in process operations.
* Builds cross-functional relationships within and across VVS and Thermo Fisher sites.
* Enhances relationships with team members.
* Works cooperatively with others to meet group and organizational goals.
* Execute hands-on cGMP manufacturing with other team members and follow detailed protocols to complete production runs in an efficient, safe and correct manner.
* Write process procedures including Process Development Records, SOPs, Production Batch Records, Raw Material Specifications, qualification protocols, etc. for new processes or equipment.
* Assist to ensure that drug product manufacturing modules operate efficiently and meet timelines and scheduled through performing required calibration, cleaning, and the review of material inventory and staging.

*Education/Experience*

* Minimum of High School Diploma / minimum 5+ years of relevant experience or superior demonstration of skill sets or background
* Preferred Associate's Degree / 3+ years of relevant industry experience in cGMP manufacturing
* Preferred Bachelor's Degree in related field / 2+ years of relevant industry experience in cGMP manufacturing.

*Knowledge, Skills, Abilities*

* Understanding of Drug Product manufacturing and general Good Manufacturing Practices (cGMP).
* Excellent communication and leadership skills.
* 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 10-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](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.