Principal Scientist Associate Director, Bioanalytical Sciences

JOB SUMMARY:      The Principal Scientist / Associate Director will provide scientific, technical and strategic leadership and oversight of Bioanalytical Science deliverables and play a pivotal role in supporting Sangamo projects from late-stage research through all later phases of the drug development process.  The individual is expected to have strong scientific know-how and demonstrated expertise in the field of bioanalytical assay design, development, troubleshooting and qualification. He or she must have excellent interpersonal skills and will work closely with representatives from research, clinical development, manufacturing and project management groups to ensure assay timelines are aligned with corporate deliverables.  He or she must be familiar with FDA guidance documents and industry white papers.   The position requires adaptability, excellent planning, organization and communication multidisciplinary skills as well as the ability to work in a fast-paced, team-oriented, environment.     ESSENTIAL FUNCTIONS:  Provide experience and leadership in the development and qualification of immunogenicity assays for both preclinical and clinical studies Responsible for managing staff in the immunogenicity assessment group to ensure orderly and timely completion of project assignments. Provide guidance and directions to Scientists and RAs on strategic thinking and leadership. Provide mentoring and career development of staff to build a strong team Oversee routine internal performance and troubleshooting of bioanalytical assays Work independently, directly and effectively with functional disciplines (research, pharmacology/toxicology, clinical and technical operations) to move project forward Participate in generation of bioanalytical reports and sections for regulatory filings Evaluate and implement new bioanalytical methods and technologies to solve challenging bioanalytical issues Represent non-clinical development group at core teams and other cross functional initiatives as needed Present scientific data and strategic plans to Sangamo senior leadership or partners, as well as at external conferences and regulatory meetings. Produce original peer-reviewed publications Keep current with changing FDA and EU regulatory requirements for bioanalysis     EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: Ph.D in biological sciences such as Immunology, Cell Biology, Biochemistry and Molecular Biology Minimum of 10+ years relevant experience in biotech or pharmaceutical assay development supporting preclinical and clinical studies.  Previous management experiencerequired  Strong immunoassay background with experience on ligand binding, immunogenicity, and enzyme/cell-based neutralization assays. Experience with soluble biomarker assays is a strong plus Experience in developing assays that meet performance requirements using different technologies including ELISA, MSD, Gyros, FACS, etc Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro and Graph Pad Prism Previous experience in gene and cell therapy highly desirable Experience in preparing documents for inclusion in regulatory submissions including filing of INDs, CTAs and BLAs Ability to build and foster cross-functional collaborations both internally and externally at Sangamo.
Salary Range: NA
Minimum Qualification
11 - 15 years

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