Senior Scientist, Chemical Development for Late-Stage CDMO

BioSpace; South San Francisco (CA); On-site; USD 140,000 - 160,000; Full time

Benefits offered by this job

Health insurance premium coverage (90%

Stock option program

Annual bonus

Cell phone stipend

Unlimited PTO

Onsite gym and snacks

Job summary

Alumis Inc. seeks a Senior Scientist, Chemical Development to lead late-stage drug substance development and oversee CDMOs. You will guide process development, tech transfer, and regulatory documentation as part of the CMC team.

The role requires a PhD with 5+ years in small molecule DS development, plus strong communication and collaboration skills. Domestic and international travel up to 25% is expected, with stock options and annual bonus.

Qualifications

• PhD required with minimum 5 years in small molecule drug substance development; external vendor/CDMO management preferred.
• Experience with late-stage drug substance tech transfer and CDMO oversight.
• Knowledge of cGMP, ICH, and regulatory requirements.

Responsibilities

• Drive CDMO activities for late-stage drug substance development, tech transfer, scale-up, process development and optimization.
• Provide technical guidance to drive phase-appropriate drug substance development.
• Serve as SME in chemical development and drive best practices and technical advancements.
• Review and approve cGMP documents, batch records, deviations and validation documents.
• Draft CMC sections of IND/IMPDs and NDA/MAAs; document development activities for filings.
• Collaborate with cross-functional CMC team to ensure timely drug substance delivery across lifecycle.
• Implement best practices and drive continuous improvements via technology and problem solving.
• Identify risks and communicate with teams across the organization.
• Work in the lab to address process chemistry issues (20–40%).
• Maintain knowledge of regulatory requirements and quality systems.

Skills

Communication

Presentation skills

Collaboration

Problem-solving

Organizational skills

Willingness to travel

Education

PhD in Organic Chemistry / Chemical Engineering or related field

Job description

Alumis Inc. seeks a Senior Scientist, Chemical Development to lead late-stage drug substance development and oversee CDMOs. You will guide process development, tech transfer, and regulatory documentation as part of the CMC team.

The role requires a PhD with 5+ years in small molecule DS development, plus strong communication and collaboration skills. Domestic and international travel up to 25% is expected, with stock options and annual bonus.