Director of Downstream Process Development | Durham, North Carolina
My client is a CDMO looking for a Director of Process Development to join their growing team in Durham, NC. The department has seen growth after a successful period during COVID and is set to continue its exponential growth over the next few years. The work is broad and varied, and the facilities are state of the art. This role will report directly into the Senior Director of Process Development, and help her run the department. The person who fills this position will be:
- Responsible for day to day technical supervision of the downstream scientists and associates. Serve as in-house advisor on key scientific discipline areas.
- Be an expert in downstream process technologies. Innovate and spearhead development of downstream process technologies that can result in significant increases in efficiency and purity.
- Operate within a cross-functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Upstream Process Development, Program Management, Analytical Development, Formulation Development.
- Have direct experience with establishing downstream processes for biologics in cGMP manufacturing settings.
- Guide staff in building scalability attributes into downstream processes.
- Experience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation.
- Coach and develop a highly talented and motivated staff base.
- Experience in operating in a client driven environment and communicating results and strategies cogently to a diverse audience.
- Full responsibility for the direction of all downstream process development activities.
- Evaluate, develop and implement new downstream technologies leading to process improvements and efficiency of operation or enable the company to showcase the excellence of our development operations. Publish papers in leading journals and present at key industry conferences as applicable.
- Assist in attracting new clients to the company through presenting and showcasing The company's technical and scientific capabilities as they apply to potential client projects. Support the development of appropriate proposals by interfacing with Business Development.
- Create working plans within DSP team to manage program load and resources & equipment.
- Develop and maintain budgets, manpower and capital requirements for downstream process development and manufacturing areas. Develop and monitor performance criteria to allow measurement and continuous improvement of efficiency and quality, thereby ensuring meeting of committed targets of on-time and error-free performance.
- Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
- Assure cGMP success through effective tech transfer and support of cGMP manufacturing. Coordinate efforts with manufacturing to achieve program success.
- Determine areas for gaining efficiency, coordinate with individual groups and ensure harmonized implementation of best practices.
- Document all activities according to the appropriate laboratory procedure and/or standard operating procedures.
- Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 15 years of technical management experience; a Master's degree with 13 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent) and at least 8 years related experience and/or training preferred. Additionally, at least 5 years’ experience serving in a relevant managerial capacity required.
- Must have knowledge of GMPs and biotechnology-derived product regulations.
- Also requires a demonstrated track record in the following key areas:
- Knowledge of downstream process development for biologics
- Ability to multi-task and handle successful execution of multiple parallel programs
- Knowledge of cGMP and manufacturing operations
- Knowledge of tech transfer
- Knowledge of good lab practices including hands on implementation
- Knowledge of regulatory guidelines, particularly those for IND filing.