Director, Analytical 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.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. 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. The Director of Analytical Development will partner with other functional leaders from Bioprocess, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization.
This position will lead the biophysical and bioassay teams to support clinical and commercial manufacture of mAbs, fusion proteins, and other novel biologics. The responsibilities include development of robust release and characterization assays, providing analytical support to other functions, oversight of assay transfer to Contract Manufacturing Organizations (CMOs) and support product release and regulatory submissions. In addition, this individual will co-chair the specification committee and 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.
- Lead analytical team to develop physiochemical and functional assays to support process and product development as well as product release.
- Manage analytical experimental design, execution and writing testing methods and qualification protocols/reports.
- Works closely with colleagues in manufacturing sciences to ensure timely analytical support for cell line, process and formulation development.
- Oversee comparability strategies and CQA assessments
- Stay current with protein analytics and introduce new technology to enhance workflow and capabilities.
- Co-chair specification committee and lead establishment of specifications for drug substance and drug products.
- Provide supervision for assay transfer and oversee CMO activities.
- Review and approve qualification reports and QC SOPs; address testing related issues at CMO's in collaboration with Quality.
- Manage reference standards and oversee critical reagent strategy.
- Manage analytical resources and strategic planning to support early and late stage projects.
- Act as a mentor for the junior staff and emphasize best practices.
- Partner with QA and Regulatory to support batch releases and regulatory submissions.
- PhD in Analytical Chemistry or related disciplines
- 12+ years of in-depth biotechnology technical experience in protein analytical development for molecules from lead selection to clinical development and commercial launch
- Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, and cell-based bioassay is required.
- Significant experience with protein characterization and comparability assessment is essential.
- Direct experiences on transfer of analytical methods to CMO's is required.
- Extensive experiences on authoring analytical sections for regulatory submissions.
- Experiences with method validation, process validation and BLA submission is preferred
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Demonstrated outside the box thinking to accelerate timeline is a plus
- Must be scientifically knowledgeable, team-orientated, and passionate about biopharmaceutical development.
- 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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