CAI is a 100% employee-owned company established in 1996 that has grown year over year to over 600 people worldwide. We provide quality, regulatory compliance, project management and other consulting services to FDA regulated and other mission critical industries.
CAI is seeking motivated Consultants to support biotech and pharmaceutical projects across the country. These are full-time opportunities with competitive compensation and benefits which include: Long Term Disability and Life Insurance provided by the company, Health insurance at very low cost to employee, 15% retirement contribution, 24 days PTO and 5 sick days per year plus financial support for continued professional education.
As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, FDA filings, quality system development, tech transfer, process engineering, QC Laboratory management, and various other operational readiness consulting for our clients.
The Consultant will be responsible for partnering with Clients to drive operational readiness through knowledge in environmental controls, QC Labs, process engineering, aseptic manufacturing, and strong project management. Ideally this consultant will have some exposure to Biologics and prior experience in growing Emerging Markets. This is a hands-on role that will require a proven ability to execute a client focused strategy while establishing strong, positive relationships with both client and internal teams.
BS Degree in a Scientific or Technical Discipline/Life or Health Sciences preferred
10+ years of experience in Pharma Quality or Regulatory preferably at the Senior Manager or Associate Director+ level
1-2+ years in Aseptic Manufacturing is preferred
Experience working cross functionally across Quality, Process Development, Tech Transfer and working with external leads in support of novel technologies
Ability to lead a program with a strong emphasis on cleaning validation, labs, deviations, and CAPA remediation's
Experience with microbiology is preferred
Experience with Phase 1-3 programs with Orphan/Breakthrough/RMAT therapy designations would be nice
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work overtime
Able to work in the US without sponsorship now or any time or in the future