NOTE: Indianapolis, IN is our Global Headquarters, but projects will be located in various places domestically and internationally. We are flexible and do not require that applicants live in any particular location. The position may require some travel for on-site visits to various project sites.

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. 

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.

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

Team-oriented

Customer-service focused

Process Engineering

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

Program/Project Management

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

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.

We act with integrity

We serve each other

We serve society

We work for our future

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.

$147,500 - $173,400 a year

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).