- Location
- Bloomington, Indiana, United States
- Department
- Quality Assurance & Regulatory Affairs
- Source
- Greenhouse
Description
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. 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.
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. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
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.
This role:
Simtra is seeking highly motivated undergraduate and graduate students for our Fall Co-op program. We look for diverse students with inquisitive minds and the desire to challenge themselves. Our Co-ops work closely with industry professionals and learn quickly how to problem solve on real-world projects that contribute to clinical research and manufacturing processes. In addition to on-the-job experience, we offer learning sessions with top leadership, site visits to local projects and social events.
The Opportunity:
The Quality Control (QC) team plays a critical role in ensuring that every sterile injectable product manufactured is safe, pure, potent, and compliant with all regulatory standards. QC is a core part of the quality culture - working with cross-functional groups - Manufacturing, Quality Assurance (QA), Engineering, and Regulatory Affairs to protect patient safety.
Responsibilities/Projects:
The QC Co-op will gain hands-on experience supporting routine laboratory testing, data analysis, and quality systems within a GMP (Good Manufacturing Practices) environment. The Co-op will be performing analyst functions in the Chemistry and Microbiology labs, perform general laboratory practices to education and build understanding all functions and parts of the lab. They will be co-authoring lab investigations and trend reports while training on data review.
Required Qualifications:
- Pursuing a BS or MS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
- Enrolled as a Junior, Senior, or graduate student
- Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- Strong attention to detail and accuracy
- Experience (classroom our industry) with laboratory safety and basic analytical techniques (i.e., pH, HPLC, spectroscopy, titration, etc.)
- Excellent written and verbal communication skills
- Ability to work collaboratively in a team environment and independently
In return, you’ll be eligible for[1]:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment 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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
