Senior Commercial Drug Substance Manufacturing Manager

Location: Alameda, California, United States; primarily office-based with time at contract manufacturing facilities and 30% domestic travel.

Salary: $151,000–$214,000 annually, plus bonus eligibility and benefits.

Company

hirify.global is a biotechnology company developing and manufacturing small-molecule drug products.

What you will do

• Provide technical and operational oversight for commercial API, drug substance, and raw materials manufacturing at CMOs and third-party laboratories.
• Manage CMO relationships, business reviews, manufacturing performance, batch yields, deviations, batch records, and follow-up actions.
• Lead supplier onboarding and raw materials qualification activities.
• Support process qualifications, process validations, cleaning validations, technology transfers, scale-up, and process improvements.
• Review and approve batch documents, master batch records, protocols, change controls, and executed batch records for batch disposition.
• Contribute to regulatory submissions and act as an internal technical subject matter expert for troubleshooting and assessments.

Requirements

• BS/BA with at least nine years of related experience, MS/MA with at least seven years, PhD with at least two years, or an equivalent combination.
• At least 12 years of experience in a cGMP pharmaceutical or biotechnology manufacturing environment.
• At least eight years of experience in commercial small-molecule API manufacturing operations.
• Experience working with CMOs in manufacturing, including regulatory, quality, and compliance oversight.
• Expertise in organic chemistry or chemical engineering, process optimization, troubleshooting, change and deviation management, technology transfer, process development, characterization, and validation.
• Proficiency in Word, Excel, and PowerPoint, with strong data analysis and written and verbal communication skills.

Nice to have

• At least two years of experience managing contract manufacturing organizations.
• Experience with CMOs in North America, the EU, and Asia.
• Certification in the assigned area.

Culture & Benefits

• Collaborative office environment with equipment including dual monitors and ergonomic chairs.
• Medical, dental, vision, life, disability, and flexible spending account benefits.
• 401(k) plan with company contributions and long-term incentives.
• 15 accrued vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days.
• Eligibility for a discretionary annual bonus and opportunity to purchase company stock.