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:

Manages/directs onboarding of new clinical and pre-clinical projects through new business proposals, early phase development, process optimization, and clinical manufacturing, utilizing a growing project management organization within our Bloomington plant. This position resides within the Business Management team, reporting to the Head of Project Management, New Business.

Key member of the Development Business Management team, assuring that a) development projects brought into the facility align to technical requirements and service model and b) operating principles and project management tools / processes are followed by the development Project Managers to drive a successful service experience by new and existing customers.

Accountable to drive the business and service model across development functions, assuring alignment to the delivery of business results while achieving high customer satisfaction through delivery of the service model. Assures customer expectations are set during the initial development on boarding process through involvement with sales, development services team, Manufacturing, Quality, Regulatory, Technical Services and the Project Managers.

What you'll do:

• Design initial workstreams and cycles for the development and clinical business group: proposal process, opportunity triage, onboarding process, kickoff structure, client business review, and additional miscellaneous Program Management support for the development team.
• Assure customer loyalty through delivery of development customer commitments
• Leads internal and external project team meetings and ensures clear actions are documented and committed enabling timeline achievement.
• Ensuring smooth transfer to commercial team upon successful completion of clinical project milestones.
• 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.
• Accountability for a) compliance of development PMs with PM standards, b) Lean principles, and c) overall technical project performance, measured by on-time delivery of milestones, forecast accuracy, execution and maintenance of timelines and risk registers
• Mentors/coach team members, supervise PMs (development), drives their performance and development
• Work closely with Development Scientists and PMs (development) to monitor cost, schedule, and performance of projects, while working to assure the ultimate success of technical projects.

What you'll bring:

• Bachelor's degree required; Graduate degree highly preferred
• 2+ years product development and/or manufacturing environment required
• 3+ years project management experience required
• Direct management and mentoring experience highly preferred
• Must be well versed in Project Management tools and must possess knowledge of related disciplines
• Strong experience with sales and early clinical/pre-clinical development processes
• Commercialization experience in a growth environment with demonstrated negotiation skills and contractual process understanding
• Experience managing multiple cross-functional teams simultaneously
• Proven experience/results with strategic leadership, communication, organization, and excellent supervisory skills
• Working knowledge of key principles. e.g., GMPs, FDA/EMEA guidelines
• Strong experience with enterprise software, e.g. JDE, BPLM, Pilgrim, Trackwise, etc.)
• PMP or equivalent certification preferred

Physical/safety requirements

• Duties may require overtime work, including nights and weekends.
• 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

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.

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