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1+ months

Director, Upstream Process Development

Kelly Services
Durham, NC 27722
Kelly Scientific is actively seeking a **Director in Upstream Process Development** in **Durham, NC** , for a direct hire (perm) opportunity. The director will manage staff in Upstream Process Development and serve as upstream process development department head overseeing planning, execution, and project delivery in a fast-paced environment.


**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 to showcase 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.

+ 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.

+ 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.

+ May serve as in-house advisor or contribute to key scientific discipline areas.


**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.

+ 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.

+ 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


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-18 Expires: 2022-07-11

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Director, Upstream Process Development

Kelly Services
Durham, NC 27722

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