Senior Drug Substance Director — GMP & CMO Strategy

Proclinical; New York (NY); On-site; USD 200,000 - 260,000; Full time

Job summary

Proclinical is seeking a Drug Substance Director for a leading biotech in New York. You will oversee global CRO/CMO networks to develop and manufacture drug substances from pre-clinical to commercial stages. The role focuses on expert process chemistry, scale-up, and regulatory submissions in a fully onsite New York setting.

You will lead cross-functional teams, ensure GMP/CMC compliance, and drive tech transfer and process development across the drug substance lifecycle.

Qualifications

• Advanced degree (PhD/Masters) in organic chemistry is required.
• Minimum of 15 years of experience in pharmaceutical or biotech industries.
• In-depth understanding of GMP requirements and CMC regulatory guidance for small molecule drug substance manufacturing.

Responsibilities

• Prepare and manage RFPs and CDMO activities with clear goals and deliverables.
• Develop and optimize synthetic routes for small molecule drug substances across development stages.
• Review and approve production documents (process description, batch records, specifications).
• Compile process and quality data from drug substance productions for performance tracking.
• Incorporate QbD principles and novel technologies for process development.
• Coordinate analytical activities for monitoring material quality.
• Collaborate with cross-functional teams to ensure seamless project progression.
• Lead tech transfer and manufacturing engagements with external CROs/CMOs to meet GMP delivery timelines.

Skills

Organic chemistry

Process chemistry

GMP/CMC knowledge

Regulatory submissions

Tech transfer

Scale-up experience

Project leadership

CRO/CMO management

Education

PhD in Organic Chemistry

Job description

Proclinical is seeking a Drug Substance Director for a leading biotech in New York. You will oversee global CRO/CMO networks to develop and manufacture drug substances from pre-clinical to commercial stages. The role focuses on expert process chemistry, scale-up, and regulatory submissions in a fully onsite New York setting.

You will lead cross-functional teams, ensure GMP/CMC compliance, and drive tech transfer and process development across the drug substance lifecycle.