CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to 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. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
We are now seeking a PMT (Tech Transfer) Discipline Lead to join our growing operations. The role of a Tech Transfer Discipline Lead in CAI is to:
· Act in a program/project oversight role, to include managing client relationships for particular projects or at a site and can do that for multiple sites simultaneously.
· Engages in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver special expertise. Works for and reports to the PMT business area leader.
· Supports the client project team. The person would also be available as an internal source of knowledge in support of proposals, our Tier III qualification program, or in response to the needs of our teams across the globe for such expertise remotely.
· Industry Thought Leader: Is engaged in industry forums, speaking, writing articles, participating in society committees, supporting standards or guidance document creation within such groups, and has a network of industry contacts who would recognize you as being an expert in Tech Transfer.
· Knowledge Management (Technical): Provide significant support to the Business Area Leader in developing the PMT quality system, knowledge management, and services definition Leader.
· Sales/Marketing: Collaboration on new ideas and demonstrates communications skills both selling PMT services and providing strategic project work. Contribute to PMT content on external web site and marketing materials.
· Leadership: Leadership experience is an advantage and can be demonstrated through leading projects, PM, CM, RM, roles etc.) as well as in other ways (coaching/mentoring, special initiatives, collateral duties, etc.). Demonstrated leadership prior to joining CAI, or in roles external to CAI will be considered.
· BSc or MSc in a relevant engineering or science field, or equivalent experience
· Excellent oral and written communication skills in English
· Customer-service focused
· Able to travel domestically and internationally if required
Tech Transfer Experience:
· Three (3) or more years of experience in Technology Transfer of:
o Support technology transfers of early pipeline to commercial products, including lifecycle management.
o Conduct make-a-batch exercises to resolve facility fit and identify gaps
o Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
o Author and/or own technology transfer and other technical documents
o Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization
o Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
o Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
o Deliver progress reports and presentations (including generation and upkeep of dashboard) to engage with and ensure that management is aware of the current status and progress
o Knowledge of analytical methods and applicable tech transfer methodology
Other Desired Experience:
· Process Engineering
o Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities
o Management of process development activities
o Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing
o Single use biomanufacturing systems
o Continuous Process Verification (CPV) (using Minitab or other statistical software)
o Process performance qualification (PPQ)
o Deviation and CAPA investigations
o Experience with biomanufacturing processes
· Program/Project Management
o Project planning and estimating
o Schedule development and execution
o Issue tracking and resolution
o Establishing metrics and leading team to achieve performance goals
o Facilitating meetings and workshops.