AddressRequired Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
JOB DESCRIPTION
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
EDUCATION
Minimum of a BS in Chemistry, Life Sciences, Engineering, Regulatory Affairs or related field in a pharmaceutical environment.
EXPERIENCE
- Minimum of 5 years of pharmaceutical experience preferably with a plant manufacturing focus
- GMP and technical writing experience with protocol and report preparation
- Experience with quality systems
- Working knowledge of validation
- Knowledge of 21 CFR 110, 21 CFR 211, ICH Q7, and other regulatory standards governing the manufacture of bulk drug substance and drug product.
- Tech transfer experience
KNOWLEDGE, SKILLS, ABILITIES
Ability to engage the organization at multiple levels. Depth of experience writing and reviewing technical reports/protocols. Basic knowledge of intermediate to advanced statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelson’s/Shewart’s rules (or other statistical trending rules), etc. Basic knowledge of mainstream statistical software analysis program such as SAS, MiniTab, or JMP as well as advanced knowledge of Process Validation principles and their application in biologics drug substance manufacturing. Demonstrated ability to build and maintain productive internal and external facing customer relationships to foster collaboration and continued process improvement
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.
Responsibilities:
Please refer the Job description for details
