Sr. Project Manager, Development (DPCS)

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. Project Manager, Development supports the Bloomington, IN Development and Pre-Commercial Services (DPCS) team as the primary leader for new method and formulation development business opportunities. This position is integral in growing the DPCS business by supporting the sales organization in assessing new opportunities, generating/reviewing project proposals, guiding clients through the development phase and assisting with department P&L calculations and reports. This role leads projects through method and formulation development, validation, and clinical production activities by ensuring that all analytical and development milestone project requirements are delivered per the agreed upon project specifications while balancing cost, resource and time commitments. The Sr. Project Manager sets appropriate Scientist, Associate, and client team member expectations through the use of Project Management tools and guidelines while ensuring effective communications is achieved with all team members. The Sr. Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems. This position reports to the Director of DPCS.

 

The responsibilities:

• Primary client facing role covering all aspects of development life-cycle, including proposal and project plan generation/review while supporting marketing and sales campaigns in order to understand client and market needs
• Participating in initial client development discussions as a technical decision maker and ensuring accurate proposal output is achieved
• Performing technical evaluations of incoming development opportunity requests, facilitating the Potential Product Evaluation and PAC meetings, initiating pricing discussions with finance, business development, sales and marketing and approving the final customized business proposal committing to scope, timeline, and cost
• Actively supporting client's method and formulation development by coordinating client's requests and follow-up questions, supporting customer relationship management and business development initiatives to ensure client satisfaction
• Key contributor to departmental profit and loss calculations and reports
• Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results
• Leads internal and external project team meetings and ensures clear actions are documented and committed enabling timeline achievement
• Ensures collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback
• Primary contact for ongoing development projects and uses best practices in communication processes; minimizes extraneous information and reduces non-essential communications; manages information appropriately with all parties while sharing