Global Director of Process and Manufacturing Technology

Flexible, Depending Upon Candidate  /  VP/Officers/Directors/Managers  /  Full Time


Position Description:
The Process & Manufacturing Technology (PMT) Business Area Leader (BAL) is responsible for establishing, growing, and leading services delivered to life sciences clients in the areas of tech transfer, new technologies, and process improvement. PMT-BAL is expected to engage in strategic billable work to establish new services, or to engage with new or existing accounts to provide high-end or door-opening services. The remainder of the time the BAL should be engaged in marketing, direct sales, sales support to regions, mentoring of Associate Directors, and/or developing the knowledge management system.
Skills and Characteristics Required:
PMT services cover the entire project and product lifecycle. From the earliest design, process and product concepts to completion and operation, we ensure that the entire operation—from planning to commissioning to full scale operation—goes smoothly and according to plan, resulting in a fully approved facility that is also highly efficient.
The services provided under PMT include:
Manufacturing Strategy, Planning & Execution
- Manufacturing roadmap, CMO assessment & selection, Site assessment & selection, Tech Transfer Strategy, Risk Assessment & Program Management, Production planning & scheduling 
Chemistry, Manufacturing & Controls (CMC)
- Product & process development / QbD , CMC section authoring (IND, NDA, BLA, Change management, tech transfer), Product, process and analytical  lifecycle management, Analytical method lifecycle management , Product & Process Knowledge Management 
Technology Transfer
- Tech Transfer PM, Tech Transfer Risk Assessment / Management , Tech Transfer Charter & Project Plan, Tech Transfer Leads: Process, Analytics, Facility & Equipment, Supply Chain, EHS 
Process Engineering
- Process design & scale-up to clinical, Process lifecycle management, Engineering studies 
Cleaning & Process Design & Qualification
- Cleaning process design consulting, Equipment design & selection consulting, Cycle development (CIP, COP, SIP) 
Manufacturing Performance Analysis & Oversight
- Statistical process analysis, Continuous process verification, Person-in-Plant (owner rep at CMO), Factory of the Future Manufacturing Innovation across the product lifecycle (Pharma 4.0, Continuous processing, Release by exception, Increasing titer / yield,  New manufacturing modalities (ATMPs)  
Requirements include:
Position Requirements:
10+ years of industry experience in manufacturing, consulting, services, and leadership.
Strong technical education preferred, with a bachelor’s degree or equivalent experience.
MBA or equivalent experience is a plus
 
Other Requirements:
Fluent in English
Excellent oral and written communication skills
Able to travel domestically and internationally as required 
US Candidates must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment 
About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
 
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity.
We serve each other.
We serve society.
We work for our future.
 
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
 
Benefits
Our full-time positions offer competitive compensation and benefits which include up to 15% retirement contribution, PTO and sick days, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
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CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country