Drug Substance Director

Proclinical Staffing; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Proclinical Staffing is seeking a Drug Substance Director for a growing biotechnology company in New York. This role requires advanced expertise in organic chemistry and 15 years of pharmaceutical or biotech experience.

The successful candidate will manage CROs and CMOs, develop synthetic processes, and oversee regulatory submissions including IND and NDA. Strong leadership skills and a comprehensive understanding of GMP are essential, as the role is fully onsite in New York.

Qualifications

• 15 years of experience in pharmaceutical or biotech industry.
• In-depth experience with CMC regulatory guidance.
• Experience managing project timelines and communication.

Responsibilities

• Manage CROs and CMOs for drug substance processes.
• Develop and optimize synthetic routes for clinical studies.
• Ensure compliance with regulatory submissions.

Skills

Expertise in synthetic routes of chemistry

Understanding of GMP requirements

Technical project leadership

Familiarity with medicinal chemistry

Hands-on experience in scaling-up organic compounds

Successful troubleshooting synthetic process issues

Knowledge of drug substance analytical methods

Strong engineering and scientific principles application

Relationship management with contract manufacturing organizations

Experience with regulatory submissions

Education

PhD/Masters in organic chemistry

Job description

Drug Substance Director – Permanent – New York

Proclinical is seeking a Drug Substance Director for an exciting and rapidly growing biotechnology company based in New York.

Primary Responsibilities

In this role, you will be utilizing and managing a global network of CROs and CMOs to develop processes and manufacture drug substance for pre‑clinical through commercial stage projects. You will be seen as an expert in synthetic routes of chemistry and process chemistry both within the company and when working with CROs/CMOs.

The position is based fully onsite in New York.

Skills & Requirements

• Advanced degree (PhD/Masters) in organic chemistry is required with a minimum of 15 years of experience in the pharmaceutical or biotech industry.
• In‑depth understanding of GMP requirements and CMC regulatory guidance for small molecule drug substance manufacturing and related quality requirements.
• Technical project leadership experience both in early‑stage and in late‑stage drug substance process development.
• Familiar with medicinal chemistry and in‑depth knowledge of organic chemistry.
• Hands‑on experience in scaling‑up organic compounds from mini‑gram to kilo‑gram scale.
• Track record of successful troubleshooting synthetic process issues.
• Understanding of drug substance analytical methods including phase‑appropriate qualification/validation requirements.
• Strong skills applying fundamental engineering and scientific principles to process design, implementation, and tech transfer.
• Experience managing and building strong relationships with contract manufacturing organizations.
• Experience with successful regulatory submissions (IND, IMPD, MAA, NDA, etc.) as well as phase‑appropriate cGMP requirements.
• First‑hand experience in writing/assisting with CMC documents for regulatory submissions.

The Drug Substance Director Will

• Prepare and manage Request for Proposals (RFPs) based on target milestones and available information for each project. Manage CDMO activities through clear communication such as defining project goals and deliverables in SOWs and ensure project execution in a timely manner.
• Develop and optimize synthetic routes and processes for small molecule drug substances supporting all stages of development including IND enabling studies, clinical studies and process validation.
• Review and approve all production related documents related to drug substances (process description, master and executed batch records, drug substance specification, etc.)
• Compile process related data and product quality data from all drug substance productions for tracking of process performance and product quality.
• Incorporate QbD principles and novel technologies for process development, as appropriate.
• Manage developmental stage‑appropriate analytical activities for monitoring material quality.
• Collaborate with cross‑functional teams, including drug discovery, analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
• Devise and execute detailed plans for tech transfer, process familiarization and manufacturing utilizing external CROs/CMOs to ensure timely delivery of GMP drug substance to a drug product facility.

Proclinical Staffing is an equal opportunity employer.