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 supports corporate, manufacturing and IT projects globally. This role represents and manages multiple projects ensuring all milestone requirements are delivered per agreed upon project specifications while balancing cost, resource, and time commitments. They set appropriate expectations using 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 projects by mitigating risk and problem solving. This position reports to the Senior Project Manager

What you’ll do:

• Leads cross functional project staff. Understands and demonstrates ownership of key activities.
• Accountable for:
  • Budget planning and performance
  • Supplier contracts, key activities, deliverables
  • Scope definition, requirements, project milestones
  • Project, staffing and communications plans
  • Management of risks, issues, dependencies
  • Escalations to leadership team
  • Standard and regular status reporting activities
  • Communications at all organizational levels
• Leads team meetings and ensures clear actions are documented and committed, enabling timeline achievement.
• Conducts presentations and facilitates meetings.
• Familiarity and proficiency with multiple project management tools
• Familiarity with Software Development Life Cycle (SLDC)
• Familiarity with one or more Project Management disciplines (Waterfall, Agile)
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with suppliers to ensure optimal results.
• Coordinates agreed upon scope change control when a change is proposed and approved
• Identifies opportunities for improvement and ensures resources take ownership and drive results.
  

What you’ll bring:

• Successful candidates must possess a bachelor’s degree preferably in a technical discipline.
• Minimum of 5 years IT project management experience required preferably within a corporate Project Management Office (PMO) within the Life Sciences industries.
• Project Management designations such as PMI, SCRUM Master preferred
• Must be well versed in Project Management tools and must possess knowledge of related disciplines
• Strong communication and interpersonal skills, able to effectively interact with and influence stakeholders at all levels. Demonstrated ability to lead collaborative initiatives and promote a culture of continuous learning and excellence.
• Computer proficiency in Microsoft Project, Word, Excel, and Outlook and the ability to use enterprise software tools
• Strong preference for candidates to be local to Parsippany, NJ.
  

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

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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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