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:
The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling, and finish services. This individual should be a strong team player with highly developed communication and problem-solving skills. This position reports to the Associate Director of Operational Execution (OPEX) and is 100% onsite.
The responsibilities:
- Evaluate potential projects from a variety of sources to determine site priority and resourcing requirements
- Develop and monitor project plans and adjust to ensure successful delivery
- Communicate progress regularly to key stakeholders and escalate potential roadblocks when identified
- Facilitate After Action Reviews (AAR) for projects to identify opportunities for improvement
- Collaborate with cross-functional team members from Operations, Quality, Technical Services to effectively and efficiently drive projects to completion
Required qualifications:
- BS degree, preferably in science or project management related field
- MS degree and/or PMP certification is a plus, but not mandatory
- 3+ years of project management experience, preferably within the pharmaceutical or other regulated industry
- Ability to manage multiple projects at the same time
- Experience leading and/or working with cross-functional teams with the ability to negotiate, influence, and drive change
- Strong oral and written communication skills
- Experience with project management tools: MS Project, Minitab, Excel (or similar programs)
- Advanced proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams)
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
- Short and Long-Term Disability 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
- Additional Benefits
- 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
- Voluntary Insurance Benefits
[1] Current benefit offerings are in effect through 12/31/24
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.
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https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy
Top Skills
What We Do
As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them.
(Simtra is a tradename of Baxter Oncology GmbH and Baxter Pharmaceutical LLC)
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