Drug Substance Consultant - Small-Molecule, Medicinal Chemistry & Process Chemistry

The Steely Group; Jersey City (NJ); Hybrid; USD 96,000 - 165,000; Part time

Job summary

The Steely Group seeks a consultant with broad expertise in medicinal and process chemistry to lead drug substance development from discovery through commercialization. The role calls for strategic direction, technical depth in synthesis routes, scale-up, and regulatory documentation for IND/NDA filings.

Ideal candidates have extensive experience in drug substance manufacturing, QbD principles, and CRO/CDMO oversight, enabling successful tech transfer and robust process performance.

Qualifications

• PhD or MS with extensive pharma/biotech experience.
• End-to-end drug substance development and manufacturing knowledge.
• Familiarity with regulatory filings (CMC sections).

Responsibilities

• Provide strategic and technical leadership for discovery, optimization, development, and manufacture of small-molecule drug substances.
• Develop drug substance synthesis routes, manufacturing processes, and transfer to manufacturing.
• Oversee scale-up, process characterization, and qualification strategies.

Skills

Medicinal chemistry

Process chemistry

Drug substance development

CMC writing

Education

PhD in Organic/ Medicinal Chemistry

Job description

Part-time (20 hours/week) | Remote We are seeking a consultant with broad expertise in medicinal chemistry and process chemistry to provide strategic and technical leadership for the drug substance development of small molecule drug candidates from discovery through commercialization. The ideal candidate will combine a strong foundation in medicinal and synthetic organic chemistry with extensive experience in drug substance process development and manufacturing to advance compounds from lead optimization through IND-enabling studies, clinical development, and commercial manufacturing.

Responsibilities:

• Provide strategic and technical leadership for the discovery, optimization, development, and manufacture of small-molecule drug substances
• Provide expertise in the development of drug substance synthesis routes, manufacturing processes, and technology transfer
• Responsible for drug substance manufacturing process scale-up, process characterization and process performance qualification strategy and execution
• Provide expertise in the synthesis and characterization of drug substance reference standards, impurity standards, metabolites, isotope labeled standards, internal standards for bioanalytical methods and other related materials
• Evaluate external manufacturing capabilities and select appropriate development partners.
• Provide oversight for CRO and CDMO activities
• Review technical proposals, development plans, and manufacturing reports.
• Conduct risk assessments for drug substance and develop risk mitigation plans
• Author and review drug substance development and manufacturing sections for global regulatory filings (IND, IMPD, NDA, MAA, etc.), and participate in regulatory interactions as necessary
• Represent drug substance development as subject matter expert (SME) on project teams, and interface cross-functionally with all key stakeholders
• Provide technical due diligence assessments for licensing or acquisition opportunities

Requirements and Preferred Skills:

• Ph.D. in Organic Chemistry, Medicinal Chemistry, Pharmaceutical Chemistry, Chemical Engineering or related discipline with 15+ years of experience, or M.S. with 20+ years of experience working in the pharmaceutical or biotechnology industry
• End-to-end small molecule drug substance expert with in-depth knowledge and hands-on experience in medicinal chemistry, process chemistry, and drug substance development and commercialization
• Proven track record advancing compounds from discovery through clinical and commercial stages
• Expertise in reference standards, internal standards, metabolites and related materials.
• Strong understanding of analytical and bioanalytical requirements associated with these materials
• Proven experience in applying Quality by Design (QbD) principles to drug substance development, manufacturing process and commercialization
• Experience with CDMO selection, technical due diligence, and external manufacturing strategy
• Proven experience writing CMC drug substance sections in regulatory filings.
• Experience supporting interactions with regulatory agencies is highly desirable
• Thorough understanding of cGMP compliance and ICH guidelines
• Excellent collaboration and communication skills