Sr. Manager, Technical Services

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 Technical Services Building Cell Manager is a part of the 4-person Building Cell leadership team along with the Engineering Manager, Manufacturing Manager and the Quality Manager. This role will manage a team of Technical Services professionals in an aseptic pharmaceutical manufacturing facility. The team is responsible for creating and owning Master Batch Records (MBR) and day-to-day technical support of the Aseptic Manufacturing Operations, including planning and performing technical studies and projects. This position reports to the Technical Services Director.

 

Essential Duties and Responsibilities:

Building Cell Leadership

• Work alongside Manufacturing, Engineering and Quality Cell leaders to fully own the performance for the operations in the Building Cell, including but not limited to:
  • Quality performance (batch release, non-conformance / right first time, corrective & preventive actions)
  • Manufacturing output (batch execution, run rates)
• Serve as the primary technical resource for issue resolution during manufacturing operations
• Drive creative technical improvements for the Building Cell leadership team
  • Ensure the Tech. Services team is aligned to support the Building Cell goals and performance
  • Fully engaged in initiatives across Technical Services functions for the Building Cell (Engineering batches, pre-PPQ demos, PPQs, CCOQs for new equipment, TS studies to drive improvements or generate data for investigations, Sterility Assurance Validations, Cleaning Validations, etc.).
    • This Technical Services Building Cell leader is not responsible for planning or executing the various technical studies owned by the centralized Technical Services groups (SAV, CV, Tech. Transfer, Process Validation, CSV). However, they will be engaged with the teams, aware of the activities needed by these groups, and facilitate getting the studies performed as necessary.
  • Work with Manufacturing, Engineering and Quality to quickly resolve manufacturing issues

 

Technical Services Team Leadership

• Manage and lead Tech. Services teams that own the master batch records (MBRs) and the Tech. Services floor support roles
  • Effectively operate in and mentor direct reports to lead cross-functional teams to complete process improvements.
  • Maintain and develop direct reports to be Subject Matter Expert (SME) for technical processes applicable for the Building Cell.
• Ensure timely and thorough investigation of manufacturing anomalies to identify batch impact, root causes, and corrective/preventative actions, and approval of investigation findings and conclusions.
• Provide technical support during client and regulatory audits (individually or team); being a technical resource for plant initiatives. 
• Approve techn