ConsultantIndianapolis, Indiana, United States

Consultant

Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering, quality / compliance, and consulting services to support our partners in finding ground-breaking treatments and solutions. We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines. Our culture of philanthropy, teamwork, training and development and commitment is the foundation to our teams' and partners' long-term success.

Project Farma is a wholly owned subsidiary of Precision Medicine Group, LLC, a leading global life sciences company with over 2,000 employees.

Position Summary :

The Consultant will work collaboratively with clients, vendors, contractors, and other Manufacturing Solutions Team Members to lead and support projects related to biomanufacturing across the entire project lifecycle. Specifically, they are responsible for leading and mentoring small project teams through Manufacturing Solution's Patient Focused and People first platform. This is accomplished through overseeing high-quality deliverables, supporting and escalating business development opportunities, and continually strengthening their technical and industry knowledge.

Essential Functions of the Job Include But Are Not Limited To :

Project Performance and Delivery

• Coordinate with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering to :
• Lead, oversee, and execute client project initiatives, plans, or workstreams including ensuring team deliverables are completed in a timely and high-quality fashion.
• Coach Team Member on identified knowledge gaps and direct Team Members to materials to develop project driven technical and problem-solving skills.
• Develop, execute, and delegate project strategy, initiatives, and vision to effectively lead a small project team.
• Provide hands-on support for both clients and PF Team Members in navigating the life cycle of cutting-edge equipment and manufacturing processes including proactively identifying and escalating roadblocks and utilizing critical thinking skills and knowledge of problem-solving skills to identify creative solutions.
• Create, update, and present work projections and progress reports.
• Develop technical documentation such as SOPs and protocols.
• Build internal and external understanding, buy-in, and commitment to decisions through mutual understanding, collaboration, and effective presentations skills.
• Mentor and train internal PF Team Members on assigned duties, industry best practices, overall understanding of the business, and project driven technical skills.
• Generate project succession plans as identified by leadership.
• Maintain and present site dashboards to communicate project health and maintenance.
• Support Site and Account Leads in proposal generation.
• Maintain PO management tools and proactively communicate PO performance.
• Coordinate Team Member utilization with Site and Account Leads and communicate and escalate discrepancies between actual and forecasted utilization.
• Maintain internal site tools such as site dashboards, deliverable trackers, etc.
• Continually develop technical aptitude of Manufacturing Solution's core services within the life science space including but not limited to :
• Capital Project Management, including Project Controls and Scheduling
• Facility Builds
• Tech Transfers
• Validation Life Cycle, including Commissioning and Qualification, Process Validation, Computer System Validation, etc.
• Quality, Regulatory, and Compliance
• GxP Automated Systems
• Quality Control, including Clinical and Commercial

Leadership and Philanthropy

Client Management and Business Development

Qualifications : Minimum Required :

Other Required :

Preferred :

In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including :