Don Low Email & Phone Number

San Mateo, Ca, Us

South San Francisco, California, Us

Leads a growing team at the intersection of genomics, computational methods and drug development. Key partner for individualized mRNA, DNA and T-Cell therapy collaborations.

South San Francisco, California, Us

Genentech technical lead for biosampling, genomics and bioinformatics group. Supporting ongoing individualized immunotherapy manufacturing, increasing process knowledge and planning for scale-out and commercial launch.

South San Francisco, California, Us

Leads site selection and manages operational aspects of outsourced API and drug product manufacturing projects. Involved in the development of the overall development CMO network for Genentech and outsourcing strategy for small molecules and cytotoxic drugs for antibody-drug conjugates. Represents the manufacturing collaborations group on technical development teams. Responsible for contract development and negotiations.

Deerfield, Illinois, Us

Led monoclonal antibody and assay reagent development projects. Responsible for coordinating the efforts of multi-functional teams. Served as primary point of contact with personnel from other Baxter sites as well as with contract manufacturing clients. Maintained project timelines, tracked milestones and deliverables. Presented regular updates to senior plant management. Wrote strategic project plans for both internal Baxter and client-based projects.

Responsible for development of new synthetic methodology for API proof-of-concept and preclinical testing. Managed research and development team with 3 PhD chemists. Mapped chemistry goals and milestones for new therapeutic platform. Oversaw outsourced production of starting materials at CMO's. Coordinated information/technology transfer from external labs.

Us

CMC Team Leader for Phase III project. Served as key contact with manufacturing partners. Established and maintained manufacturing relationships to ensure supply of clinical material. Contributed to IND and EMEA IMPD filings. Oversaw future process design and modification in close collaboration with partners. Led team that included members from quality, analytical, formulation, regulatory, manufacturing and legal functions.

Principal Investigator and author of $2 million award from NIST Advanced Technology Program. Led interdisciplinary team using novel drug discovery platform merging protein chemistry and combinatorial biology. Drove collaboration with German and American partners and maintained key relationship with NIST personnel. Cross functional team leader interacted with toxicology, biology, chemistry, regulatory, business development and legal departments.

Led and managed GMP production and scaleup of polymer-modified protein therapeutics for Phase I and preclinical trials including synthetic EPO and anti-HIV chemokines. Coauthored CMC sections of IND filings. Established and oversaw science and business interactions with external peptide synthesis companies. Negotiated pricing and transferred technology for outsourcing. Analyzed COGs for Gryphon products. Primary technology transfer contact with overseas manufacturing (Avecia) and domestic strategic partners (Hoffman-LaRoche).

Systematically explored the impact of protein architecture on active site reactivity using proteins with non-natural amino acids and hydrogen bond knockouts. Authored and awarded NIH Postdoctoral Fellowship. Invited speaker at two Gordon Conferences.

Phd, Chemistry

Ba, Chemistry