Director, Drug Substance Manufacturing & Scale-Up

GondolaBio; Palo Alto (CA); On-site; USD 188,000 - 213,000; Full time

Benefits offered by this job

Patient Days

Flexible PTO

Access to learning and development resources

Job summary

A clinical-stage biopharmaceutical company in California is seeking an Associate Director/Director for Drug Substance Manufacturing. This role involves overseeing drug substance development and managing CROs. Candidates should have a PhD in Organic Chemistry and at least 10 years of experience in process development. The company fosters a collaborative environment and offers a competitive compensation package. Join us in advancing therapies for genetic diseases.

Qualifications

• 10+ years of process development and manufacturing experience in the pharmaceutical industry.
• Experience in drafting relevant sections IND/IMPD and NDAs for regulatory filings.
• Ability to work in cross-functional teams.

Responsibilities

• Lead process development and supply chain of drug substances.
• Review and approve master batch records.
• Manage CMOs/CROs to deliver APIs on time.

Skills

Process development

cGMP practices

Strong knowledge of US FDA guidelines

Communication skills

Education

PhD in Organic Chemistry

Job description

A clinical-stage biopharmaceutical company in California is seeking an Associate Director/Director for Drug Substance Manufacturing. This role involves overseeing drug substance development and managing CROs. Candidates should have a PhD in Organic Chemistry and at least 10 years of experience in process development. The company fosters a collaborative environment and offers a competitive compensation package. Join us in advancing therapies for genetic diseases.