Director of Downstream Process Development
Location: Durham, North Carolina
- Manage staff in Downstream Process Development.
- 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 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 company through presenting and showcasing KBl'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.
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Posting ID: 609326319Posted: 2021-05-05Job Title: Director Downstream Process Development