Senior Project Manager, New Business

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 Senior Project Manager, New Business acts as the primary leader for new business opportunities and client transfer activities. This role leads projects through process development, validation, and commercialization activities by ensuring that all milestone requirements are delivered per agreed upon project specifications while balancing cost, resource and time commitments. They set appropriate customer and client team member expectations through the use of Project Management tools and guidelines while mentoring junior members of the Program Management team. The Senior Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems.

This position reports to the Senior Manager, New Business in Bloomington, Indiana. 

The responsibilities:

• Demonstrates service model ownership and leads customer and client team Members and ownership of key activities.
• Leads/participates in Program Management (PM) maturation and/or facility projects.
• Supervises junior members of the PM group.
• Leads team meetings and ensures clear actions are documented/committed enabling timeline achievement.
• Ensures collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback.
• Primary contact for ongoing technical clients’ projects and uses best practices in communication processes.
• Minimizes extraneous information and reduces non-essential communications. Manages information appropriately with all parties while sharing feedback and insight to drive improvements.
• Establishes expectations with all stakeholders and customers through clearly documented processes (DIAL, Scope Document, Timeline, and SharePoint). Ensures understanding through direct and active communication channels.
• Provides central point of contact for customer, ensures customer is communicating with appropriate personnel at the correct levels of the organization.
• Builds customer loyalty by first seeking understanding of requirements then by developing and/or implementing new processes for issues as they arise.
• Determines appropriate service recovery response and deliver message and appropriate action to customer while coordinating with internal partners.
• Successfully manages trade-offs between customer service, profitability and
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with clients to ensure optimal results (conducts risk assessment).
• Manages project interdependencies by use of project management tools that support monitor/control and effective risk management.
• Utilizes project metrics and ensures facility personnel understand progress and critical attention areas.
• Achieves billable project activities per business guidelines and approved project plans. Works with customer and sales to ensure additional work activities are billed and that the project meets profit guidelines.
• Ensures financial obligations are assessed/collected from customer due to changes, additions in project scope.
• Contributes technical and product knowledge throughout the project lifecycle and understands balance and timing of involving appropriate technical resources throughout the project lifecycle through other experts when needed.

Required qualifications:

• Bachelor’s degree required, preferably in an engineering or scientific discipline. MBA preferred.
• Minimum of five years product development or manufacturing experience required and five years project management experience, preferably in a service business.
• Must be well versed in Project Management tools and must possess knowledge of related disciplines.
• PMI or equivalent certification desired.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Veeva, Trackwise, etc.).

Physical / safety 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

In return, you’ll be eligible for [1]:

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

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.