The Tech Transfer Associate Director, also known as a Discipline Lead (DL) is a recognized Tech Transfer expert, who can 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. Has a special metrics-based bonus plan. 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.
We are looking for a candidate that has several or all keys area in the following:
1. 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.
2. Knowledge Management (Technical): Provide significant support to the Business Area Leader in developing the PMT quality system, knowledge management, and services definition Leader.
3. 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.
4. 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.
Tech Transfer Experience:
Three (3) or more years of experience in Technology Transfer of:
Support technology transfers of early pipeline to commercial products, including lifecycle management.
Conduct make-a-batch exercises to resolve facility fit and identify gaps
Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
Author and/or own technology transfer and other technical documents
Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
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
Knowledge of analytical methods and applicable tech transfer methodology
BSc or MSc in a relevant engineering or science field, or equivalent experience
Other Desired Experience:
Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities
Management of process development activities
Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing
Single use biomanufacturing systems
Continuous Process Verification (CPV) (using Minitab or other statistical software)
Process performance qualification (PPQ)
Deviation and CAPA investigations
Experience with biomanufacturing processes
Project planning and estimating
Schedule development and execution
Issue tracking and resolution
Establishing metrics and leading team to achieve performance goals
Facilitating meetings and workshops
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
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
CAI is a 100% employee-owned company established in 1996 that has grown to nearly 800 people worldwide. We provide program and project management, commissioning, qualification, validation, start-up 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. That is how we have grown exponentially.