Sheri Louis
West Greenwich
Summary
Experience
Self motivated individual with a strong work ethic who welcomes new challenges. Known for exceptional problem-solving skills and ability to work proactively with cross-functional teams. Reliable and adaptable, consistently adapting to evolving business needs while maintaining a strong focus on achieving quality results.
Overview
12
12
years of professional experience
Work History
Senior Associate Manufacturing
Takeda
Lexington, MA
10.2009 - 06.2020
- Responsible for making solid decisions on issues that arise in production and contact a supervisor as needed.
- Capable of reaching out to the appropriate resources.
- Lead all production activities to ensure efficiency and a smooth transition for the oncoming shift.
- Update shift exchange notes for 3 departments and communicate all applicable information to oncoming shift including any process issues that would impact their schedule.
- Perform and lead tasks associated with support related functions including assembling and sterilization of sub-assembly items.
- Material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use location, inventory accuracy and process kitting.
- Participate in weekly safety walkthroughs to assess overall condition of the manufacturing areas.
- Ensure that training is up to date and compliant with myself and my peers.
- Experienced in an all disposable Cell Culture process including monitoring of cells and critical parameters.
- Perform and lead change outs of Media feed stations for the perfusion step and change out of base solutions for the bioreactors.
- Also standardize equipment needed for Cell Culture (ie; Nova Bioflex, Waterbath and Benchtop centrifuge set up and standardizing the spectrophotometer for Recovery operations).
- Some experience with the Unicorn system (CIP and storing the Chromatography column).
- 20 years experience in a cGMP environment (Biotech manufacturing) including 5 start up projects and CIP development activities.
- Experience with Delta-V, Honeywell automated systems, Trackwise (training and deviations), CCMS maintenance work order system, LIMS, and SAP and ERP.
- Perform routine operations for the production of commercial products including formulating Media and Buffer solutions.
- Write and edit SOP’s as needed.
- Subject Matter Expert on all applicable procedures and train employees as needed.
- Initiation of work orders and Deviations as needed.
- Prioritize daily activities for efficiency while maintaining a compliant and safe environment.
- Standardize all equipment needed for the next day in Cell Culture, Recovery, Media and Buffer.
Shift Lead Central Services
Lonza
Hopkinton, MA
03.2008 - 10.2009
- Created 50 plus SOP’s and provided input on others (to support new manufacturing areas).
- Reviewed and approved start up protocols including IC’s, FC’s and OQ’s.
- Make solutions on a daily basis following a client or suite specific schedule.
- Train others on CIP/SIP operations used at Lonza.
- Interacted with vendors to order equipment and materials needed for the new manufacturing suite.
- Ensure the oncoming shift has a detailed list of tasks needed for the day.
- Proficient with Delta V.
Education
High School Diploma -
Chariho High School
Wood River Junction, RI06-1986
Skills
Customer service
Inventory control
Quality mind set
Manufacturing background
Timeline
Senior Associate Manufacturing
Takeda
10.2009 - 06.2020
Shift Lead Central Services
Lonza
03.2008 - 10.2009
High School Diploma -
Chariho High School