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Position Description:

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.

Requirements include:

Position Requirements:

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

Other Requirements:

Excellent oral and written English is required

Able to travel domestically and internationally if required

Able to work (paid) overtime

Able to work in the US without sponsorship now or any time or in the future

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

Annual salary range: $128,300 - $150,700 USD

Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, 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.

#LI-MR1

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company.We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).