Scientist III, Manufacturing Sciences
at Thermo Fisher Scientific
St. Louis, MO 63134, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 17 Nov, 2024 | Not Specified | 17 Aug, 2024 | 3 year(s) or above | Microsoft Word,Gmp,Process Analysis,Excel | No | No |
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Description:
EDUCATION
- Bachelor’s degree required in a scientific field, preferably an engineering field.
- 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master’s degree in a scientific field + 3 years’ experience or Ph.D.).
EXPERIENCE
- 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master’s degree in a scientific field + 3 years’ experience or Ph.D.).
- Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.
- Ability to self-motivate, prioritize work and time.
- Demonstrates a foundation in general scientific practices, principles, and concepts.
- Writes and communicates effectively.
- Ability to work both independently and as part of a team.
- Knowledge of current Good Manufacturing Practices and US/EU regulations.
- Intermediate knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.
- Proficient in Microsoft Word and Excel.
- Ability to stand for prolonged periods of time and gown into manufacturing areas.
Responsibilities:
- Draft, review and approve Standard Operation Procedures, and Job Aids and collaborate internally to ensure scientifically sound and robust procedures.
- Collaborate with the process development to develop standardized methodologies and learn/explore new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
- Contribute to Internal and Customer meetings based upon sound evidence guided by minimal direction.
- Manages internal projects and tasks and lead client projects and handle timelines with minimal support from supervision.
- Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures.
- Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process.
- Lead changes to equipment and process design, proactively and with minimal direction.
- Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
- Draft, review, and approve Process control documents, campaign summary report and process validation reports
- Reviews, analyzes and trends process data without supervision
- Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
- Solve technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.
- Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
- Provides development and training for Process Engineers/Scientists.
REQUIREMENT SUMMARY
Min:3.0Max:5.0 year(s)
Pharmaceuticals
Engineering Design / R&D
Clinical Pharmacy
Graduate
A scientific field preferably an engineering field
Proficient
1
St. Louis, MO 63134, USA