Simtra BioPharma Solutions
Principal Manufacturing Science and Technology (MSAT) Representative
Bloomington, Indiana, United States · Principal
Sponsorship not specifiedDetected 12 days ago
Supply ChainProcess ImprovementCustomer SupportGMPResearchMicrosoft Office
About the role
- Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.
- Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide.
Responsibilities
- Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
- Serve as the lead technical expert among a cross functional team
- Lead the cross functional team through technical activities, development studies and PPQ batches
- Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
- Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
- Lead during hand-off to the commercial team following PPQ batches
- Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
- Perform filter troubleshooting
- Develops and presents in-depth SME courses on pharmaceutical industry topics
Requirements
- Use of hands and fingers to manipulate office equipment is required
- Must be able to qualify for Grade A/B area gowning
- Must be able to wear applicable personal protective equipment (PPE)
- For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Equal opportunity
- Simtra is an equal opportunity employer.
- Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
- EEO is the Law
- EEO is the law - Poster Supplement
Apply directly at Simtra BioPharma Solutions →Create a free account for alerts like thisView Simtra BioPharma Solutions immigration profile
This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.