Sr. Manager, Aseptic Operations

Simtra Bio Pharma 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  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.

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.

The Sr. Manager of Aseptic Operations has responsibility for all operations occurring within their respective Aseptic Operations Cell at the Bloomington, Indiana site. As a member of the Cell Leadership Team alongside their Quality, Engineering & Maintenance, and Technical Services Sr. Manager counterparts, the Sr. Manager of Aseptic Operations has responsibility for strategic leadership of the operations organization in their respective Aseptic Operations Cell, reporting to the Director of Aseptic Operations.

The Sr. Manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Sr. Manager, Aseptic Operations creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

• As the Operations leader within the Cell Leadership Team, the Sr. Manager of Aseptic Operations has accountability for successful execution of the manufacturing plan to deliver on the site’s two primary KPIs:
  Right First Time and On Time Delivery
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Must believe in 6S…it is the foundation of quality and a lean enterprise. Setting the example is not the only thing in influencing others, it is the main thing
• Defines value for products/services from a customer perspective; focuses and aligns all actions of building leadership team and its team members to create value for the customer
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic…