Simtra BioPharma Solutions
Manufacturing Science and Technology (MSAT)
Bloomington, Indiana, United States · Senior
Sponsorship not specifiedDetected 12 days ago
ExcelSupply ChainProcess ImprovementCustomer SupportGMPResearchMicrosoft Office
About the role
- Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.
- 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.
- As such, there is a strong emphasis on quality and continuous improvement at Simtra.
Responsibilities
- Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
- Lead the cross-functional team through technical activities, development studies and PPQ batches
- Create technical transfer documents supporting this goal [Technical 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 while being visible on the manufacturing floor and resolving issues during manufacturing
- Leads process improvement activities
- Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
- Perform filter troubleshooting
- Develop and present in-depth SME courses on pharmaceutical industry topics
Requirements
- BS degree, preferably in a science or engineering related field
- 7+ years pharmaceutical manufacturing experience
- 3+ years of applicable Technical Transfer/Process Development experience
- Expertise in aseptic processing, sterile filtration, and Process Validation
- Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
- Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)
- Must be able to qualify for Grade A/B area gowning
- Must be able to wear applicable personal protective equipment (PPE)
Benefits
- Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
Company info
- With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Equal opportunity
- Simtra is proud to be 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
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