Director, Cell Line and Cell Culture BioProcess Development
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
Reporting to the VP Manufacturing Sciences, this position will be responsible for providing strategic input relates to CMC decisions and will contribute significantly to the development and success of the Manufacturing Sciences team. Partner with other functional leaders from Analytical, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization.
This position will lead the Cell line and Cell Culture Bioprocess team for clinical and commercial manufacture of mAbs, fusion proteins and other novel biologics. The responsibilities include development of cell line and cell culture process, production of preclinical supplies at in-house bioprocess pilot plant, oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support of regulatory submissions. In addition, this individual will be accountable for overall management of the function such as resource planning, employee engagement and workflow enhancement.
Essential Functions and Duties
- Key member of the Manufacturing Sciences leadership team to assess and support CMC strategy
- Oversee cell line development for the selection of production cell line for master cell bank manufacturing.
- Lead cell culture process development, optimization, characterization/validation, scale up and technology transfer to CMO's.
- Manage process development experimental design, execution and writing process development plans/reports.
- Introduce new technology to enhance workflow and capabilities.
- Manage bioprocess suite, trouble-shooting of processes, instrumentation, and equipment to ensure timely in-house manufacturing to support preclinical animal studies.
- Provide supervision for technology transfer and oversee CMO activities. Review, or approve batch records and SOPs; address production issues at CMO's in collaboration with quality and regulatory teams.
- Acts as a mentor for the junior staff, provide coaching and emphasize best practices.
- Partner with QA and Regulatory to support batch releases and regulatory submissions.
- PhD in biochemistry, chemical/biochemical engineering or related disciplines
- 12+ years of in-depth technical experience in cell culture bioprocess development for protein drugs.
- Solid knowledge and experiences in mammalian cell culture process engineering and process scale-up/scale-down design is essential.
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Strong business acumen and critical thinking
- Proven experience in process characterization and validation.
- Hands on experiences with technology transfer of manufacturing process.
- Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development.
- Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Excellent interpersonal communication and presentation skills.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
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