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Senior Scientist, Analytical Development, CMC

Employer
Bolt Biotherapeutics
Location
Redwood City, CA
Start date
Mar 10, 2023

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Job Details

Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancer.

The Position
The successful candidate will be a key contributor as a large molecule analytical characterization professional at Bolt. The position will be responsible for in depth product characterizations to build product knowledge, understand structure and function relations and supporting IND/BLA filing, for common monoclonal antibody and antibody-drug conjugates. The position will also be responsible for product specific CQAs evaluations, control strategies setting for specs and comparability studies, and supporting process characterizations. This position reports to the Analytical Development Head.

Key Responsibilities
• Develop analytical characterization methods (especially LCMS based) to characterize biologics drug product
• Independently planning and executing activities in area of product characterization
o Comparability study
o Product characterizations
• Manage CRO lab for product characterization packages, including primary, secondary, and higher order structure characterization of biologics
• Provide support to cross functional activities
• Support CMC programs representing AD function

Job Requirements
• BA/BS degree with at least 12 years post BS/BA post (8 years MA/MS, 2-5 years Ph.D.)
• Protein analytical developmental and experience at a life-science company
• Proficient with HPLC MS based analytical analysis of monoclonal antibodies and antibody conjugates and understand the operation and principles of the LCMS technologies
• Experience with Thermo Orbitrap is a plus
• Knowledge of compliance landscape of a GMP environment and demonstrate a working familiarity with GxP regulations, industry guidance and pharmacopeia
• Great communication skills and aptitude with written documentation, such as technical reports, protocols, and standard operating procedures
• Ability to perform in a fast-paced dynamic environment independently and manage tight timelines
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
 
Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Bolt will consider requests for Reasonable Accommodations.
 
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Company

Bolt Biotherapeutics was founded in 2015 by Dr. Edgar G. Engleman of Stanford University to expand upon his pioneering work in cancer immunotherapeutics and myeloid biology. Bolt is based in the San Francisco Bay area.

Bolt’s highly qualified management team includes experienced leaders in immuno-oncology drug discovery, development and commercialization. Our goal is to leverage our myeloid biology expertise to discover, develop and commercialize transformative treatments to address key unmet medical needs for patients with cancer.

Company info
Website
Phone
(650) 665-9295
Location
900 Chesapeake Drive
Redwood City
CA
94063
US

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