Tech Transfer Project Manager

Location: Raleigh, NC
Department: Azzur of North Carolina, LLC

Job Description

Job Description:

Remote position supporting a manufacturing site in Italy: Required shift starting at 5AM to ~2PM to support European Time Zone

Providing project management team direction and coordination of all activities associated with tech transfer of a biologics process.
Requires broad knowledge and experience with planning for achieving the project objectives/milestones (facility and process engineering/commissioning/validation and associated Quality System compliance targets for the the product development phase/track (clinical or commercial etc.)
Requires understanding of regulatory documentation expectations for CMC dossier,
Validation Master Planning and Quality System functions.
Ability through demonstrated experience with identifying and mitigating/negotiating project risks from a variety of sources: Engineering/Facility Construction schedule commitments and pre-requisites for CQV; Process and Analytical Development/Delivery track; Resource capacity & competency; supply chain impact; regulatory barriers/challenges etc.
BS degree with 7-10 years relevant experience as a Tech Transfer SME
MS degree with 5-7 years relevant experience as a Tech Transfer SME
Strong project management capabilities with SME in Process Validation

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Apply Now

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