Associate Director, Drug Product Development (CMC)

BBOT; San Francisco (CA); On-site; USD 188,500 - 219,000; Full time

Benefits offered by this job

Equity participation

Annual bonus

Medical, dental, and vision benefits

Retirement plan

Wellness stipend

Flexible time off

Job summary

BBOT, a clinical-stage biopharmaceutical company, seeks an Associate Director of Drug Product Development to lead formulation and process development for small molecules from preclinical through commercial stages. You will oversee solid oral dosage forms, manage external CDMOs, and collaborate with cross-functional CMC teams.

You will design phase-appropriate clinical formulations, author regulatory filings, ensure GMP/ICH compliance, and travel up to 20% to manufacturing campaigns and partner

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of industry experience.
• M.S. with 12+ years of industry experience.

Responsibilities

• Lead the drug product development strategy for assigned programs, including solid oral dosage forms.
• Design, review, and oversee formulation development, process development, and technology transfer activities.
• Develop phase-appropriate clinical formulations with a view to program success on aggressive development timelines.
• Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings.

Skills

Drug product development

CDMO management

Formulation design

Process optimization

Regulatory submissions

QbD & DoE

Oncology drug development

Education

Ph.D. in Chemistry/Pharmaceutical Sciences/CE or related field

M.S. with 12+ years of experience

Job description

BBOT, a clinical-stage biopharmaceutical company, seeks an Associate Director of Drug Product Development to lead formulation and process development for small molecules from preclinical through commercial stages. You will oversee solid oral dosage forms, manage external CDMOs, and collaborate with cross-functional CMC teams.

You will design phase-appropriate clinical formulations, author regulatory filings, ensure GMP/ICH compliance, and travel up to 20% to manufacturing campaigns and partner