For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:
The Project Manager, New Business supports the Bloomington, IN Business Management team as the primary leader for new business opportunities and client transfer activities. This position is integral in growing the business by supporting the sales organization in assessing new opportunities, generating project proposals and supporting contract negotiations. 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. The Project Manager sets appropriate customer and client team member expectations through the use of Project Management tools and guidelines while ensuring effective communications are achieved with all team members. The Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems. This position resides within the Business Management organization and reports to the Head of Project Management, New Business.

What you’ll do:

• Primary client facing role covering all aspects of product life-cycle, including proposal, contract, technical transfer and validation through commercialization. Supporting marketing and sales campaigns in order to understand client and market needs
• Performing technical evaluations of incoming new project opportunity requests, facilitating the Potential Product Evaluation and PAC meetings, initiating pricing discussions with finance, business development, sales and marketing and writing the final customized business proposal committing to scope, timeline, and cost.
• Participating in contract negotiations as decision maker for technical and site-specific business topics, as well as contract enforcement following agreement execution.
• Actively supporting client‘s filing by coordinating client‘s requests and follow-up questions, supporting customer relationship management and business development initiatives to ensure client satisfaction.
• Ensuring smooth transfer to commercial team upon successful completion of project tech transfer and validation.
• Ownership of the Client Forecasting and Demand/Supply Obligations (Sales & Operations Planning).
• Ownership of client program Quarterly Business Review Meetings.
• 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 client 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 (Project Tracker, Scope Document, Timeline, and SharePoint). Ensures understanding through direct and active communication channels.
• Determine appropriate service recovery response and deliver message and appropriate action to customer while coordinating with internal partners. Effectively manages trade-offs between customer service, profitability and capabilities.
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with clients to ensure optimal results. Manages project interdependencies by use of project management tools that support monitor/control and effective risk management.
• Coordinates agreed upon scope change control when a change is proposed, ensuring financial obligations are assessed/collected from customer due to changes or additions to project scope.
• Utilizes Action Item List, timelines, project scorecards, project metrics, and deliverable tracking to drive project performance and ensure facility personnel understand progress and critical attention areas.
• Identifies opportunities for improvement and ensures internal partners take ownership and drive results.
• 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.
• 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.

What you’ll bring:

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

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 required
• Ability to qualify for Grade C gowning required

Equal Employment Opportunity

Simtra is 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.

EEO is the Law EEO is the law - Poster Supplement 
Pay Transparency Policy

Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy