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 D365 Site Business Process Owner serves as the business owner and subject matter expert for Microsoft Dynamics 365 Supply Chain Management at the Bloomington site. This role is responsible for ERP governance, business process optimization, compliance, data integrity, system enhancements, and user adoption across Supply Chain, Manufacturing, Quality, Finance, and IT functions. The position ensures D365 supports operational excellence, GMP compliance, and business growth within a regulated pharmaceutical manufacturing environment.
The responsibilities:
- Own and govern the D365 platform, including roadmap planning, system enhancements, and business process alignment.
- Partner with Supply Chain, Manufacturing, Procurement, Warehousing, and Planning teams to optimize end-to-end operations.
- Ensure compliance with GMP, data integrity, validation, and regulatory requirements.
- Manage master data governance, including items, BOMs, routings, vendors, customers, and inventory data.
- Lead ERP-related projects, upgrades, integrations, testing, change controls, and deployments.
- Develop operational dashboards, KPI reporting, and analytics to support data-driven decision making.
- Support user training, adoption, issue resolution, and continuous improvement initiatives.
Required qualifications:
- Bachelor’s degree in Supply Chain, Operations, Engineering, Information Systems, Business, or related field.
- 5+ years supporting ERP systems in a manufacturing environment.
- 3+ years of Microsoft Dynamics 365 Supply Chain Management experience.
- Experience in regulated manufacturing (pharmaceutical, biotech, medical device, etc.).
- Strong knowledge of supply chain, inventory, procurement, warehousing, and production processes.
- Experience with validation, change management, project leadership, and process improvement.
Preferred qualifications:
- Experience in pharmaceutical contract manufacturing (CMO/CDMO).
- Knowledge of GMP/GxP and FDA regulations.
- Experience with D365 integrations (MES, LIMS, WMS, EDI, Planning, Quality systems).
- APICS/ASCM (CPIM, CSCP) and/or Lean Six Sigma certifications.
- Experience leading ERP implementations or large-scale system transformations.
Physical / Safety Requirements:
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position may require sitting or standing for long hours of time
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/
Skills Required
- Bachelor's degree in Supply Chain Management, Operations, Engineering, Information Systems, Business Administration, or related field.
- 5+ years of experience supporting ERP systems in a manufacturing environment.
- 3+ years of hands-on Microsoft Dynamics 365 Supply Chain Management experience.
- Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Strong understanding of supply chain planning, inventory management, procurement, warehousing, and production processes.
- Experience with system validation and change control processes.
- Demonstrated project management and business process improvement experience.
- Strong analytical, problem-solving, and communication skills.
- Experience in pharmaceutical contract manufacturing (CMO/CDMO).
- Knowledge of GMP, GxP, FDA, and regulatory requirements.
- Experience with production orders, batch manufacturing, inventory traceability, serialization, and warehouse management.
- Experience supporting D365 integrations with MES, LIMS, WMS, EDI, planning, or quality systems.
- APICS/ASCM certification (CPIM, CSCP).
- Lean Six Sigma certification.
- Experience leading ERP implementations or significant system transformations.
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)
