Associate Project Manager, New Clinical 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.

The role:

The Associate Project Manager, Clinical New Business is located at the Simtra BioPharma Solutions contract manufacturing site in Bloomington, IN. The Associate Project Manager provides project support and ensures execution of assigned deliverables for clients and attainment of project objectives and client satisfaction. This position resides within the Business Management organization and reports to the Sr. Manger, Clinical New Business. 

The responsibilities:

• Independently manages smaller scope transfer projects independently, functioning as the principal interface with the client.
• Independently manage project sub-work streams (as part of a large project) as assigned, acting as a secondary client interface for larger more complex projects with multiple work streams.
• Ensure timely project metric analysis is completed and maintained to be used as a guide resulting in optimal sales execution and attainment of goals.
• Support Senior Project Managers and Project Managers with various activities to meet client needs, including the following: sample management, coordination of shipments, data collection, documentation requests, etc.
• Identify, develop, and implement solutions to resolve a variety of problems. Create and maintain project reporting and analysis.
• Participate and/or lead program management department maturation projects.
• Assist with client service billing of all client programs, including the following: batches, research & development studies, stability services, shipping/materials charges, storage fees, Regulatory Affairs support, technical transfer and development activities, finance charges, etc.
• Manage and track data related to billing and payments to support plant and overall business metrics
• Host clients on site for business review meetings, batch observation, investigation support, process improvement initiatives, etc.

Required qualifications:

• Bachelor’s degree required
• Background in pharmaceutical manufacturing strongly preferred.
• Two plus years of customer service and project management related experience preferred.
• General understanding of Project Management tools and processes preferred.
• Computer proficiency in Microsoft Word, Excel, Project, and Outlook and the ability to use enterprise software (examples include: ERP, Veeva, Trackwise, etc.)
• Experience with data tracking and analysis.

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.
• Use of hands and fingers to manipulate office equipment is required
• Ability to qualify for Grade C gowning.

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
• 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 12/31/24

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.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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