Senior Manager, Drug Substance — CDMO & Process Development

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 135,000 - 215,000; Full time

Benefits offered by this job

Hybrid work model

Discretionary annual bonus

Restricted stock units

Job summary

Rhythm Pharmaceuticals Inc. is seeking a Senior Manager, Drug Substance to oversee development and manufacturing oversight with CDMOs across clinical stages.

The role ensures process chemistry development, transfer, and regulatory alignment for Drug Substances and intermediates at Rhythm’s Boston operations in a hybrid work setting. The role requires 6+ years in small molecule Drug Substances, strong cGMP knowledge, and leadership experience with cross-functional teams.

Qualifications

• Project management and leadership experience in pharma/chemistry teams.
• Strong skills in process development and tech transfer.
• Demonstrated ability to manage CDMOs and external vendors.
• Excellent written and verbal communication.
• Ability to make risk-based decisions in fast-paced environments.

Responsibilities

• Oversee CDMO teams in scale-up of intermediates and APIs for GLP studies and GMP clinical studies.
• Collaborate with CDMOs to address process chemistry challenges and develop scalable, safe and cost-effective processes.
• Perform route scouting and development activities for small molecule Drug Substances.
• Assist with technology transfers between CDMO suppliers.
• Review and approve manufacturing batch records.
• Assist with closing out supplier deviations and investigations.
• Write and review Drug Substance related technical documents.

Skills

Project management

Process development

CDMO management

Communication skills

Risk assessment

Education

BS in Chemistry

MS in Chemistry

Job description

Rhythm Pharmaceuticals Inc. is seeking a Senior Manager, Drug Substance to oversee development and manufacturing oversight with CDMOs across clinical stages.

The role ensures process chemistry development, transfer, and regulatory alignment for Drug Substances and intermediates at Rhythm’s Boston operations in a hybrid work setting. The role requires 6+ years in small molecule Drug Substances, strong cGMP knowledge, and leadership experience with cross-functional teams.