Senior Manager, Program Management

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 Sr. Manager of Transfer Programs - Program Management oversees and directs the onboarding of new projects through new business proposals, technical transfer, clinical manufacturing, process validation, and scale up/line changes of existing commercial projects in a 10+ project management organization from our Bloomington, Indiana Contract Manufacturing location. This key leader ensures projects brought into the facility align to the business guidelines, technical requirements, and service model. The Sr. Manager ensures customer expectations are set during the on boarding process through involvement with sales, the Project Manager, and the client service team. This position interfaces with key functional leaders from Manufacturing, Quality, Regulatory, Technical Services, Supply Chain, Sales, Contract Management, Marketing, Legal and R&D in a leadership / facilitator capacity. As a key member of the Program Management leadership team this individual is accountable to drive the business and service model across the functions and ensure alignment to the delivery of business results while achieving high customer satisfaction through delivery of the service model. The Sr. Manager ensures that the key operating principles and project management tools / processes are followed by the Sr. Project Managers to ensure a successful service experience by new and existing customers.

The responsibilities:

• Under general supervision of the Director, Program Management, responsible for leading key Customer Service initiatives and ensures customer loyalty through delivery of customer commitments.
• Strong knowledge of Sales and Technical Transfer Processes.
• Accountable for compliance of transfer PMs with PM standards.
• Establishes and maintains strong customer relationships in alignment with contract enforcement and the project plan.
• Responsible for the P&L for total of transfer projects (S&OP forecast accuracy, invoicing and A/R).
• Mentors and coaches team members and supervise PMs and Sr. PMs (Transfer). Drives performance improvement and development of technical project managers.
• Works with sales and marketing groups to assess new opportunities and resources to achieve new business opportunities.
• Accountable for overall technical project performance as measured by on-time delivery of milestones, forecast accuracy, execution and maintenance of timelines and risk registers.
• Works with Senior PM and PMs (Transfer) to monitor cost, schedule, and performance of projects, while working to ensure the ultimate success of technical projects.
• Accountable for compliance of transfer PMs with Lean principles; leads by example.
• Communicates with Company and Customer executives regarding the status of the projects and/or portfolio.
• Participates in contract negotiations.
• Sponsors PM improvement projects such as PM matur