Skip to main content

This job has expired

You will need to login before you can apply for a job.

Lead Scientist, Downstream Process Development

Employer
Bolt Biotherapeutics
Location
Redwood City, CA
Start date
Jul 18, 2021

View more

Job Details

Lead Scientist of Downstream Process Development

The Position:

The success candidate will join Bolt CMC team as downstream process development (DSP) functional lead., shall have responsibility for leading downstream process development and technical transfer for manufacturing recombinant proteins. The individual will oversee the DSP activities at the external CDMO, author CMC regulatory submissions, and in-house operations to support Bolt's development pipeline. The position will report to the Director (Process Development & Manufacturing).

About You You will be responsible for development of purification and UF/DF processes that are scalable, robust and transferable to GMP manufacturing operation for the production of high-quality protein therapeutics for human clinical use , performing gap and risk analysis, as required. You will author and/or review/approve of manufacturing master batch records, and standard operating procedures, process specifications and in- process testing plans. You will lead, review and/or approve investigations/troubleshooting and closure of OOS/OOT, deviations and excursions, and CAPA with QA. You will need to independently author, review and approve portions of the CMC Regulatory sections (IND, BLA, etc). You will manage activities including project timeline and budget (personnel, equipment, etc) and laboratory.

Job Requirement includes:

• Educational degrees in chemical engineering, bioengineering, biology, biochemistry or related area

• Ph.D. with 6+ years, MS with 10+ years, BS with 15+ years of direct experience in DSP Operations

• Extensive hands-on experiences in purification at various industrial scales, operational is required.

• Thorough knowledge of protein downstream process techniques including chromatography, filtration, centrifugation, and In-process analysis

• Scale down/up experiences and development using QbD

• Extensive experience in antibody and/or antibody conjugate process development

• Experience with cGMP regulation & guidance and working in a GMP environment

• Excellent communication, technical writing, organizational and collaboration skills; good decision-making risk-assessment, and leadership

• Experience with regulatory filings required

• Experience managing CMO/CRO’s required

• Experience with management or building of a developmental laboratory desirable

• Proficient with the use of MS Office software and DSP application and DOE software

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 that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

We are an Equal Opportunity Employer offering a competitive salary and benefits package.

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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert