Simtra BioPharma Solutions
MSAT Senior Associate (Tech Transfer)
Bloomington, Indiana, United States · Senior
Sponsorship not specifiedDetected 18 hours 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 & 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 clinical and/or 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, GMP clinical/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. The position is visible on the Manufacturing floor, resolves issues during manufacturing and leads process improvement activities.
- Grade A/B gowning qualification. Will enter Grade B areas for Batch support
- Trained and will perform filter troubleshooting
- Develops and presents in-depth SME courses on pharmaceutical industry topics
Requirements
- Bachelor's degree required, preferably in a science or engineering related field.
- In-depth expertise in aseptic processing, sterile filtration, and clinical manufacturing and/or Process Validation
- Five (5) years pharmaceutical manufacturing experience, with a minimum of 3 years of applicable MSAT/Tech Transfer/Process Development experience.
- Computer proficiency in Microsoft Word,
- 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).
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MiniTab, Trackwise, etc.)
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
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance 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.
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