Director of Validation

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 Director of Validation plays a strategic leadership role in the growth and continued operational excellence at Project Farma in order to advance our mission of accelerating market access for next-generation medicines.  Specifically, the Director of Validation is responsible for the mentorship and development of the next generation of PF leaders, providing strategy and industry expertise in key engineering and manufacturing projects, owning business development initiatives, and managing resource allocation for a given market(s).  Lastly, the ideal Director of Validation candidate will maintain a strong focus on Project Farma’s Patient Focused philosophy and represent the organization in alignment with our core values.   

Essential functions of the job include but are not limited to: 

Mentorship and Development  

• Mentor, train, and coach Team Members including Managers, Technical Project Managers, and Project Engineers in technical performance, client engagement, and leadership skills  
• Engage in strategic succession planning initiatives to ensure the readiness of future thought leaders 
• Coach Managers on best practices for Team Member engagement and retention 
• Build and maintain a high performing Team ensuring client retention and expansion  

Operational Management  

• Present monthly resource projections to Leadership team 
• Strategically creates structures and processes to ensure project Team Members have the required tools, training, and systems to perform their duties  
• Create project schedules for project tasks and drive alignment back into the overall program schedule
• Provide resource planning, as well as define project objectives and requirements necessary to structure a project or activity
• Author and manage summary reports 

Business Development  

• Owns Business Development for current and potential partnerships  
• Represent PF as an industry leader who interfaces with clients in Site & Project Lead capabilities  
• Attend and represent PF at ISPE or other regional networking events 
• Lead, organize, and attend client events and celebrations
• Lead Regional PF Business Development Meetings
• Lead weekly client touch point meetings with new and existing PF clients  

Strategy and Industry Expertise  

• Lead project teams and provide direction throughout project delivery life cycle
• Engage with design teams early in the life cycle to fully comprehend design scope 
• Be a Subject Matter Expert who provides high level technical direction in the following areas: 
  • Cell and Gene Therapy 
  • Capital Projects
  • Facility Builds
  • Tech Transfers 
  • Validation Life Cycle 
  • Commissioning and Qualification 
  • Quality, Regulatory, and Compliance 
  • Engineering Automation and Serialization 
  • Reliability, Maintenance, and Asset Management  

Qualifications: 

Minimum Required: 

• Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience 
• A minimum of 10 years of advanced therapy, life science, pharmaceutical, or biotech experience 

Other Required: 

• Full COVID-19 Vaccination is required prior to the employee's start date with exceptions for medical and religious accommodations when reasonable 
• As a consulting company, this position may require a willingness to travel. 

Preferred: 

• A minimum of 5 years consulting and/or project management experience 

Skills: 

• Great soft skills, excellent verbal and written communication
• Effective time management, prioritization, and follow through
• Value committed with a high level of integrity
• Dedicated work ethic
• Demonstrate strong personal attributes that include teamwork, professionalism and the ability to see the “big picture” 

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

• Competitive salary based on experience 
• Aggressive bonus structure  
• Medical, Dental, and Vision insurance effective your first day of employment  
• 401k Plan with company match 
• Paid Time Off and Company Paid Holidays
• Company Paid Maternity and Parental Leave
• Continuing Education Assistance