- Lead CMC strategy from development candidate (DC) selection through GMP clinical supply for early clinical programs.
- Provide hands‑on leadership across drug substance, drug product, analytical development, stability, and clinical supply readiness.
- Guide formulation development to achieve target exposures and toxicology margins; ensure phase‑appropriate control strategies.
- Oversee analytical method development/validation, reference standards, and stability programs in alignment with ICH Q1.
- Manage clinical packaging, labeling, and supply chain readiness to support Phase 1 execution.
- Serve as the CMC lead on cross‑functional program teams, proactively identifying and managing technical and regulatory risk.
- Lead selection and governance of external partners (CDMOs, CROs, labs), including SOWs, budgets, timelines, quality, and performance.
- Author and review CMC sections of regulatory submissions, including INDs and amendments, and support health authority interactions.
- Build and mentor CMC capabilities as the organization scales.
- PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field (MS/BS with significant relevant experience considered).
- 10+ years of increasing responsibility leading CMC for small‑molecule programs, with multiple INDs filed.
- Demonstrated leadership across DS/DP, analytical, stability, and GMP clinical supply.
- Strong track record of vendor governance and scientific/regulatory writing.
- Strategic, pragmatic, and comfortable operating in fast‑paced environments.
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+We are seeking a Senior Director to lead end-to-end Chemistry Manufacturing and Controls strategy for a growing small-molecule pipeline.+ · +PhD in Chemistry Chemical Engineering Pharmaceutical Sciences or related field · 10+ years of increasing responsibility leading CMC for s ...
Boston2 weeks ago
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We are seeking a rigorous, investigative Research Analyst with excellent communication skills to join the Drug Hunter team to cover case studies in small molecule drug discovery. You will be responsible for researching, writing, editing and producing content that analyzes scienti ...
Boston, Massachusetts, United States2 weeks ago
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Research Analyst position at Drug Hunter to cover case studies in small molecule drug discovery. · We are seeking a rigorous, investigative Research Analyst with excellent communication skills to join the Drug Hunter team. · ...
Boston5 days ago
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We seek a Senior Director to lead end-to-end Chemistry Manufacturing and Controls strategy for small-molecule pipeline. · Lead CMC strategy from development candidate selection through GMP clinical supply. · Provide hands-on leadership across drug substance drug product analytica ...
Boston, MA2 weeks ago
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We're looking for someone with extensive experience in drug R&D—ideally from a large pharma environment—who can provide scientific vision, · operational discipline, · and BD-savvy leadership. · &prioritization, &portfolio diversification · ...
Boston1 month ago
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The intern will join the In-Silico Small Molecule (ISSM) group to support research on saturation metrics and methods for assessing how well molecular scaffolds have been explored. · Must be a current student enrolled at an accredited college or university pursuing at least a bach ...
Lexington, MA InternshipSHIP2 weeks ago
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We are building for the future creating a distinct R&D community based on collaboration partnerships and cutting-edge research across multiple modalities and therapeutic areas. · The ProgramAt Novo Nordisk interns will have the opportunity to work closely with experienced industr ...
Lexington $52,000 - $89,000 (USD) InternshipSHIP2 weeks ago
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We are recruiting an engineer for a consulting engagement with our direct client, a leading global biotechnology company. · This role requires supporting the process development and technical transfer of client's synthetic drug substance processes by first demonstrating scale-up ...
Cambridge, MA · Biotech/Pharmaceutical2 weeks ago
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The intern will join the In-Silico Small Molecule (ISSM) group to support research on saturation metrics and methods for assessing how well molecular scaffolds have been explored... · ...
Lexington, MA InternshipSHIP2 weeks ago
- Work in company
Scientist II, Small Molecule Process Development and Manufacturing
Only for registered members
+We are seeking a highly motivated and creative individual to join our Small Molecule Chemical Development team. This position provides an exciting opportunity to develop robust processes for the synthesis of a wide range of Small Molecules across various modalities.+ · +Route sc ...
Cambridge $114,000 - $152,000 (USD) Full time2 weeks ago
- Work in company
Scientist II, Small Molecule Process Development and Manufacturing
Only for registered members
We are seeking a highly motivated and creative individual to join our Small Molecule Chemical Development team.This position provides an exciting opportunity to develop robust processes for the synthesis of a wide range of Small Molecules across various modalities. · ...
Cambridge $114,000 - $152,000 (USD)2 weeks ago
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Provide process engineering support in batch or continuous API platforms through application of chemical engineering and process chemistry fundamentals from clinical to commercial stage. · ...
Cambridge3 weeks ago
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Process Engineer III/ IV- Small Molecule/ Oligo/ Peptide
Only for registered members
CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our cli ...
Boston, MA2 days ago
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As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen's small molecule portfolio. · ...
Cambridge $155,000 - $214,000 (USD) Full time2 weeks ago
- Work in company
Scientist II, Small Molecule Process Development and Manufacturing
Only for registered members
About This Role · We are seeking a highly motivated and creative individual to join our Small Molecule Chemical Development team. This position provides an exciting opportunity to develop robust processes for the synthesis of a wide range of Small Molecules across various modal ...
Cambridge, MA1 day ago
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External Manufacturing Associate Director, Drug Product Small Molecule
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The External Manufacturing Associate Director role is a key member of Vertex's External Manufacturing Organization (ExM), providing support, strategic insights and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO). This leader ...
Boston $160,000 - $240,000 (USD) Full time6 days ago
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External Manufacturing Associate Director, Drug Product Small Molecule
Only for registered members
The External Manufacturing Associate Director role is a key member of Vertex's External Manufacturing Organization (ExM), providing support, strategic insights · This leader will cultivate and leverage multiple cross-functional business relationships to identify and execute creat ...
Boston $160,000 - $240,000 (USD)6 days ago
- Work in company
External Manufacturing Associate Director, Drug Product Small Molecule
Only for registered members
The External Manufacturing Associate Director role is a key member of Vertex's External Manufacturing Organization (ExM), providing support and strategic insights to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO). This leader will cultivate and le ...
Boston, MA5 days ago
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Global Manufacturing Sciences Process Science Lead – Small Molecules API
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This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject matter expert and primary technical contact for Takeda's small molecule API manufacturing for synthetic drug substance across the product lifecycle. · ...
Boston1 week ago
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Machine learning applied to Quantitative Pharmacology - Small molecules Fall 2026 Co-op
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Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research in R&D.The Quantitative Pharmacology (QP) group is seeking a Machine learning co-op to aid in developing machine ML models supporting drug prioritization. · ...
Cambridge2 weeks ago
Senior Director, CMC – Small Molecules - Boston - Genepool Networks
Description
Overview
We are seeking a Senior Director, CMC to lead end‑to‑end Chemistry, Manufacturing, and Controls strategy for a growing small‑molecule pipeline. This role will own CMC from development candidate selection through INDs and Phase 1 clinical supply, working in a highly cross‑functional and externally partnered environment.
Key Responsibilities
Qualifications
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Senior Director, CMC – Small Molecules
Only for registered members Boston
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Research Analyst, Small Molecule Modalities
Only for registered members Boston, Massachusetts, United States
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Research Analyst, Small Molecule Modalities
Only for registered members Boston
-
Senior Director, CMC – Small Molecules
Only for registered members Boston, MA
-
Chief Scientific Officer of Small Molecule Business
Only for registered members Boston
-
Internship - Small Molecule Cheminformatics
InternshipSHIP Only for registered members Lexington, MA
-
Internship - Small Molecule Cheminformatics
InternshipSHIP Only for registered members Lexington
-
Engineer, Synthetics/Small Molecule Processes (JP13329)
Only for registered members Cambridge, MA · Biotech/Pharmaceutical
-
Internship - Small Molecule Cheminformatics
InternshipSHIP Only for registered members Lexington, MA
-
Scientist II, Small Molecule Process Development and Manufacturing
Full time Only for registered members Cambridge
-
Scientist II, Small Molecule Process Development and Manufacturing
Only for registered members Cambridge
-
Process Engineer Small Molecules API Process Science
Only for registered members Cambridge
-
Process Engineer III/ IV- Small Molecule/ Oligo/ Peptide
Only for registered members Boston, MA
-
Associate Director, Regulatory CMC Small Molecule Lead
Full time Only for registered members Cambridge
-
Scientist II, Small Molecule Process Development and Manufacturing
Only for registered members Cambridge, MA
-
External Manufacturing Associate Director, Drug Product Small Molecule
Full time Only for registered members Boston
-
External Manufacturing Associate Director, Drug Product Small Molecule
Only for registered members Boston
-
External Manufacturing Associate Director, Drug Product Small Molecule
Only for registered members Boston, MA
-
Global Manufacturing Sciences Process Science Lead – Small Molecules API
Only for registered members Boston
-
Machine learning applied to Quantitative Pharmacology - Small molecules Fall 2026 Co-op
Only for registered members Cambridge