IT Enhancement Manager

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 Enhancement Manager supports corporate, manufacturing and IT system enhancement requests. This role manages the intake, definition, prioritization, assignment and disposition of all system enhancement requests globally. They assist in clear definition, estimating and setting expectations for completion if appropriate, while ensuring effective communications with all team members and stakeholders. The Enhancement Manager ensures all requests are tracked, reported on and assigned as appropriate. This position will also evaluate current processes and reporting functions to identify improvement and efficiency opportunities. This position reports to the VP of Program and Project Management. This position reports to the Senior Manager, Commercial Programs in Bloomington, Indiana.

 

The responsibilities:

• Creates and fosters effective relationships with IT leadership and business sponsors.
• Accountable for:
  o Managing enhancement requests (intake).
  o Owning and improving the enhancement request and disposition process
  o Ensuring requests are well defined and complete
  o Working with requestors to further define/justify requests where appropriate.
  o Collaborate with technology and business stakeholders to prioritize requests.
  o Shephard review process to disposition and allocate resources.
  o Gather weekly and monthly reporting for multiple levels of business and technology leadership.
  o Foster effective relationships with business partners, setting expectations, partnering and enforcing process adherence.
  o Ensure adherence to all validation requirements and standards.
  o Escalates to the leadership team as appropriate.
  o Standard and regular status reporting activities.
  o Communications at all organizational levels.
• Leads review meetings and ensure clear actions are documented, assigned and followed up on.
• Conduct presentations and facilitate meetings.
• Familiarity with technology-based support, enhancement and project processes.
• Familiarity with one or more Project Management disciplines (Waterfall, Agile) is helpful.
• Identifies opportunities for process improvement and makes recommendations
• Identifies opportunities for enhancement execution acceleration and works with leadership to overcome resourcing constraints Primary contact for ongoing commercial client projects with emphasis on ensuring successful execution of production plan to achieve or exceed sales forecast

Required qualifications:

• Successful candidates will typically possess a bachelor’s degree in technical discipline with business management acumen.
• Minimum of 6 years IT application support, enhancement execution or leadership of small IT projects.
• Preferably within Life Science industries.
• Strong communication at all levels, internal and external
• Computer proficiency in Microsoft Project, Word, Excel, and Outlook and