Project Manager, New Business

About Simtra BioPharma Solutions

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—all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra, holding 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 Simtra?

• 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 to 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 by taking on challenges big and small to improve patient health.

Responsibilities

• Primary client-facing role covering all aspects of the product life-cycle, including proposal, contract, technical transfer, validation, and commercialization.
• Support marketing and sales campaigns to understand client and market needs.
• Perform technical evaluations of incoming new project opportunity requests, facilitate Potential Product Evaluation and PAC meetings, initiate pricing discussions with finance, business development, sales, and marketing, and write the final customized business proposal committing to scope, timeline, and cost.
• Participate in contract negotiations as a decision-maker for technical and site-specific business topics, as well as contract enforcement following agreement execution.
• Actively support client filings by coordinating requests and follow-up questions, managing customer relationships, and ensuring client satisfaction.
• Ensure smooth transfer to the commercial team upon successful completion of project tech transfer and validation.
• Ownership of Client Forecasting and Demand/Supply Obligations (Sales & Operations Planning).
• Ownership of client program Quarterly Business Review Meetings.
• Ensure roles and responsibilities are clear across internal and external organizations to achieve desired results.
• Lead internal and external project team meetings, ensuring clear actions are documented and committed to enable timeline achievement.
• Ensure collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback.
• Serve as the primary contact for ongoing client projects, using best practices in communication processes to minimize extraneous information and reduce non-essential communications.
• Manage information appropriately with all parties while sharing feedback and insight to drive improvements.
• Establish expectations with all stakeholders and customers through clearly documented processes (Project Tracker, Scope Document, Timeline, and SharePoint) and ensure understanding through direct and active communication channels.
• Determine appropriate service recovery responses and deliver messages and actions to customers while coordinating with internal partners.
• Effectively manage trade-offs between customer service, profitability, and capabilities.
• Anticipate project challenges and risk scenarios, preparing and leading proactive mitigation strategies internally and/or with clients to ensure optimal results.
• Manage project interdependencies using project management tools that support monitor/control and effective risk management.
• Coordinate agreed-upon scope change control when a change is proposed, ensuring financial obligations are assessed and collected from the customer due to changes or additions to project scope.
• Utilize Action Item Lists, timelines, project scorecards, project metrics, and deliverable tracking to drive project performance and ensure facility personnel understand progress and critical attention areas.
• Identify opportunities for improvement and ensure internal partners take ownership and drive results.
• Achieve billable project activities per business guidelines and approved project plans, working with customers and sales to ensure additional work activities are billed and that the project meets profit guidelines.
• Contribute technical and product knowledge throughout the project lifecycle and understand the balance and timing of involving appropriate technical resources as needed.

Requirements

• Bachelor’s degree required, preferably in a business or scientific discipline.
• Minimum of three years of pharmaceutical product development or manufacturing experience preferred, along with three years of project management experience, preferably in a service business.
• Must be well-versed in Project Management tools and possess knowledge of related disciplines.
• PMP certification desired.
• Computer proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook, and the ability to use enterprise software (e.g., ERP, Veeva, Trackwise, SalesForce).

Physical Requirements

• Duties may require overtime work, including nights and weekends.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Ability to qualify for Grade C gowning required.

Benefits

• Day One Benefits including Medical & Dental Coverage, Flexible Spending Accounts, Life and AD&D Insurance, Supplemental Life Insurance, Spouse Life Insurance, and Child Life Insurance.
• 401(k) Retirement Savings Plan with Company Match.
• Time Off Program including Paid Holidays, Paid Time Off, Paid Parental Leave, and more.
• Adoption Reimbursement Program and Education Assistance Program.
• Employee Assistance Program and Community and Volunteer Service Program.
• Employee Ownership Plan.
• Additional Benefits including Short and Long-Term Disability Insurance, Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity), Identity Theft Protection, Legal, and more.
• Onsite Campus Amenities including Workout Facility, Cafeteria, and Credit Union.

Current benefit offerings are in effect through 12/31/26.