Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Location/Division Specific Information
St. Louis, MO / Drug Substance Division - This is one of the five divisions that make up the Pharma Services Group. We specialize in both small and large molecule development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally!
What are the work hours?
This opening is for 6:00AM - 6:30 PM. This is a 12 hour, rotating 2/2/3 schedule (2 days on, 2 days off, 3 days on - you will work every other weekend).
How will you make an impact:
The candidate will perform operations in support of the manufacture of Commercial and Clinical Biologics. They will perform following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to preparation and organization of the downstream processing manufacturing suites.
What will you do?
Ensure all consumables for production processes are accounted for upon delivery to stage process consumables in an organized manner for ease of use in production set-ups
Assist with obtaining and placement of raw materials and consumables at/from the wipe-down station for entrance into the suite
Collaborate with production support groups to ensure lines, kits, and assemblies are ready when needed within manufacturing and any missing components can be acquired timely.
Ensure material kits are complete and available for manufacturing use prior to set up of process step. Confirm buffers are available prior to need. Ensure buffers move to the downstream manufacturing suites so production processing is not halted and on time processing needs are met
Support ancillary tasks on the manufacturing floor such as fit and finish, material stock/supply and equipment staging.
Assist with inventory counts within the production suites and coordinates results with Inventory Leads and Procurement.
Performs or assists with investigations when discrepancies of inventory are discovered.
Assist in all manufacturing process functions, such as maintaining suite, supplies with site SOPs and policies.
Ensure tasks are completed with a method of prioritization - interpret production schedules and complete tasks accordingly.
Participate in shift exchanges, 1-1's, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).
Education
High school diploma or GED is required. Associates in a relevant scientific field preferred.
Experience
0-3 confirmed experience in a related field (regulatory cleaning/manufacturing preferred)
Science experience related to pharmaceutical industry preferred.
Must be a self-starter who can take general concepts and direction and produce desirable results.
Basic knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment preferred.
Knowledge, Skills, Abilities
Knowledge
Understanding 'why' and not just the 'how' of processes and practices
Knowledge of cGMP practices, aseptic techniques, or chemical concepts seen as a plus
Skills
Proficient with PCs (Personal Computers) and use of Windows applications such as MS Excel, MS .
Word and MS PPT is required.
Inventory Management - SAP experience a plus.
Time management and prioritization.
Abilities
Ability to read, write and speak English fluently.
Ability to understand and carry out instructions.
Good problem-solving and critical thinking skills.
Excellent organization skills.
Effective communication (written and verbal).
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
