Senior Scientist, Chemical Development

Location: South San Francisco, United States; onsite role with up to 25% domestic and international travel, including Asian countries

Salary: $140,000–$160,000 USD annually, plus stock options and an annual bonus program

Company

hirify.global is a precision medicines company developing treatments intended to improve outcomes for patients with autoimmune diseases.

What you will do

• Drive late-stage drug substance development and manufacturing activities at CDMOs, including technology transfer, scale-up, process development, and optimization.
• Provide technical guidance and oversee internal and external activities for phase-appropriate drug substance development.
• Review and approve cGMP documents, including batch records, change controls, deviations, specifications, and validation documentation.
• Draft CMC sections of regulatory filings, including IND/IMPDs and NDA/MAAs, and prepare development source reports.
• Collaborate with the cross-functional CMC team to ensure timely drug substance delivery throughout the drug lifecycle.
• Work in the laboratory 20%–40% of the time to solve process chemistry issues and drive continuous improvement.

Requirements

• PhD in Organic Chemistry, Chemical Engineering, or a related field, with at least 5 years of small-molecule drug substance development experience; alternatively, an MS with at least 8 years of experience.
• Experience with late-stage drug substance technical transfer and management of external vendors, CROs, or CDMOs.
• Experience developing control strategies and applying QbD principles to commercially viable manufacturing processes.
• Knowledge of cGMP, ICH, and regulatory requirements.
• Highly proficient written and spoken English; ability to travel domestically and internationally up to 25% of the time.
• Strong collaboration, problem-solving, organizational, communication, and presentation skills.

Nice to have

• Bilingual Japanese and English proficiency, including the ability to provide technical translation for written and verbal communication and technical documents.
• Experience working in a fast-paced small-company environment.

Culture & Benefits

• Collaborative, hardworking environment focused on improving patients’ lives.
• Stock option grants for all employees and an annual bonus program.
• Health insurance premiums covered at 90% for employees and 80% for dependents.
• Unlimited PTO for exempt employees.
• Free onsite gym, stocked kitchen, Genentech Bus & Ferry Share access, and a $100 monthly cell phone stipend.