Company: Thermo Fisher Scientific Inc.
Posted on: June 12, 2021
Job Title: Associate I
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
Location/Division Specific Information
Alachua, FL - Viral Vector Services Division
How will you make an impact?
The Associate I 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 Upstream Manufacturing Leadership.
What will you do?
This position requires routine hands-on bioprocess manufacturing
within a cGMP cleanroom commensurate with the individual's level of
technical expertise, training, and qualification strictly following
defined procedures. Responsibilities include performing basic
bioprocess manufacturing activities and operating bioprocessing
equipment, meticulous documentation, monitoring of processing
equipment, processes, and control systems within a GMP cleanroom
for the manufacture of viral vectors. In addition, the
Manufacturing Associate is expected to keep the GMP cleanroom in a
constant state of inspection readiness and perform routine tasks
such as cleaning, chemical and waste management, equipment
maintenance, materials movement and other duties as assigned to
assure the cleanroom and manufacturing systems are clean and
inspection ready at all times. The Manufacturing Associate will
adhere to all Safety and Quality standards of the organization
contribute to continuous improvement in the areas of Safety,
Quality, and Delivery.
Drug Product GMP Production (90% of time spent on floor)
- Fully trained on all unit operations associated with the
Upstream Manufacturing department .
- 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 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.
- Performs equipment testing and routine troubleshooting and
maintain an up to date skills matrix.
- Support and conduct other sub-team (Upstream, Downstream,
Support Operations) tasks and related production processes, when
Prepare and Review Documents (10%)
- Review and train on manufacturing batch records.
- Complete preventative maintenance and work notifications tasks
- 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 Supervisors to review, revise, and author Work
Instructions (WI)/SOPs/Material Specifications (SPEC).
- Assist in the optimization of upstream processes for
- Assist in the technical transfer of processes from Process
Development laboratories to manufacturing.
- High School Diploma / minimum 1+ years of relevant experience
or superior demonstration of skill sets or background
- Preferred Bachelor's Degree in related field / 0+ year of
relevant industry experience
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,
- This position will start as a fulltime, Mon - Fri, 40-hour work
- 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.
Keywords: Thermo Fisher Scientific Inc., Gainesville , Associate I, Other , Alachua, Florida
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