Head of Upstream PD

Posted 04 November 2022
LocationUnited States of America
Job type Permanent
Contact NameSam Heron

Job description

About the job

  • Manage staff in Upstream Process Development.
  • Serves as upstream process development department head overseeing planning, execution and project delivery in a fast-paced environment.
  • Actively provides career path and development for team members.
  • Determines areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices.
  • Have a working knowledge of upstream process technologies.
  • Support innovation and development of upstream 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, Downstream Process Development, Program Management, Analytical Development, Formulation Development.
  • Have direct experience with establishing upstream processes for biologics in cGMP manufacturing settings.
  • Experience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation.
  • Experience in operating in a client driven environment and communicating results and strategies cogently to a diverse audience.
  • May serve as in-house advisor or contribute to key scientific discipline areas.
  • Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
Job Responsibilities:
  • Full responsibility for the operations of all upstream process development activities.
  • 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.
  • Support the development and maintenance of budgets, manpower and capital requirements for upstream 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.
  • Support the development and implementation of new upstream technologies leading to process improvements and efficiency of operation or enabling showcase of the excellence of our development operations.
  • Assist in attracting new clients through presenting and showcasing 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 USP team to manage program load and resources & equipment.
  • 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 Requirements:
  • 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 10 years related experience and/or training preferred. Additionally, at least 5 years’ experience serving in a relevant managerial capacity required.
  • Management experience must include managing a team of at least 10.
  • Must have knowledge of GMPs and biotechnology-derived product regulations.
  • Also requires a demonstrated track record in the following key areas:
  • Knowledge of upstream 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.