Senior Scientist, Chemical Development
Alumis
August 23, 2026
On-site
South San Francisco, CA
Clinical Research and Development
Senior Scientist, Chemical Development (CMC)
Responsibilities:
- Drive CDMO activities for late-stage drug substance development and manufacturing (tech transfer, scale-up, process development, optimization).
- Provide technical guidance and oversight to drive phase-appropriate drug substance development.
- Serve as subject matter expert in chemical development and advance best practices.
- Review/approve cGMP documents (batch records, change controls, deviations, specs, validation master plan, validation protocols/reports).
- Draft CMC sections of regulatory filings (IND/IMPDs, NDA/MAAs).
- Document development activities as source reports for regulatory filings.
- Collaborate with cross-functional CMC team to ensure timely drug substance delivery across the lifecycle.
- Implement continuous improvements via technology innovation and problem-solving.
- Proactively identify risks and communicate with teams across the organization.
- Work in the lab to solve process chemistry issues (20%–40%).
- Ensure knowledge/application of cGMP, ICH, and regulatory requirements.
Qualifications/Required:
- PhD in Organic Chemistry, Chemical Engineering, or related field.
- Minimum 5 years’ experience in small molecule drug substance development (or MS with 8+ years—desirable) including external vendor/CDMO management.
Preferred Skills:
- Late-stage drug substance technical transfer experience.
- Control strategy development; QbD experience to develop commercially viable manufacturing processes.
- Strong oral/written communication and presentation skills.
- Collaboration, problem-solving, organizational skills.
- Ability to travel domestically/internationally (incl. Asia) up to 25%.
- Bilingual Japanese/English; able to translate technical communication/documents (strongly preferred).
Benefits/Compensation:
- Salary range: $140,000–$160,000 USD annually.
- Bonus program and stock option grants.
- Health insurance premiums: 90% employee / 80% dependents.
- Genentech Bus & Ferry Share access.
- $100 monthly cell phone stipend.
- Unlimited PTO for exempt employees.
- Free onsite gym and stocked kitchen.
Responsibilities:
- Drive CDMO activities for late-stage drug substance development and manufacturing (tech transfer, scale-up, process development, optimization).
- Provide technical guidance and oversight to drive phase-appropriate drug substance development.
- Serve as subject matter expert in chemical development and advance best practices.
- Review/approve cGMP documents (batch records, change controls, deviations, specs, validation master plan, validation protocols/reports).
- Draft CMC sections of regulatory filings (IND/IMPDs, NDA/MAAs).
- Document development activities as source reports for regulatory filings.
- Collaborate with cross-functional CMC team to ensure timely drug substance delivery across the lifecycle.
- Implement continuous improvements via technology innovation and problem-solving.
- Proactively identify risks and communicate with teams across the organization.
- Work in the lab to solve process chemistry issues (20%–40%).
- Ensure knowledge/application of cGMP, ICH, and regulatory requirements.
Qualifications/Required:
- PhD in Organic Chemistry, Chemical Engineering, or related field.
- Minimum 5 years’ experience in small molecule drug substance development (or MS with 8+ years—desirable) including external vendor/CDMO management.
Preferred Skills:
- Late-stage drug substance technical transfer experience.
- Control strategy development; QbD experience to develop commercially viable manufacturing processes.
- Strong oral/written communication and presentation skills.
- Collaboration, problem-solving, organizational skills.
- Ability to travel domestically/internationally (incl. Asia) up to 25%.
- Bilingual Japanese/English; able to translate technical communication/documents (strongly preferred).
Benefits/Compensation:
- Salary range: $140,000–$160,000 USD annually.
- Bonus program and stock option grants.
- Health insurance premiums: 90% employee / 80% dependents.
- Genentech Bus & Ferry Share access.
- $100 monthly cell phone stipend.
- Unlimited PTO for exempt employees.
- Free onsite gym and stocked kitchen.