Analytical Development Principal Scientist
Vertex Pharmaceuticals
August 07, 2026
On-site
Boston, MA
Operations
General Summary:
Vertex is seeking an experienced scientist to develop cutting-edge small molecules and the analytical control science underpinning their syntheses as part of the Drug Substance Control Strategy team in Analytical Development.
Key Duties and Responsibilities:
- Collaboratively design and oversee drug substance process development analytical activities across all phases, including late phase development following Quality by Design (QbD) principles.
- Set and justify specifications for drug substance, intermediates, and starting materials, considering clinical study design, toxicology support, CMC processes, and regulatory guidelines.
- Identify critical in-process-control (IPC) issues and develop appropriate IPC methods.
- Serve as subject matter expert for drug substance analytical development with contract manufacturing and testing labs.
- Develop analytical methods suitable for progressive stages of pharmaceutical development.
- Justify retest period, storage, and shipping conditions for starting materials and intermediates.
- Understand chemical development and solid-state development to identify and document critical factors impacting quality and method performance.
- Develop and review source documents for regulatory submissions.
- Present to cross-functional teams and communicate analytical issues and solutions.
Knowledge and Skills:
- Excellent verbal and written communication.
- Control strategy development experience; spike/purge studies; drug substance QbD process development.
- Working knowledge of cGMP, ICH, FDA, and USP guidelines, including impurity control and nitrosamines.
- Modern small-molecule analytical skills, particularly chromatography.
- Ability to work independently and in a team/matrix environment; manage multiple projects in a fast-paced setting.
Education and Experience:
- Ph.D. with 4+ years analytical development experience (small molecule drug substances). MS (7+ years) or BS (10+ years) also considered.
- Background in modern synthetic organic chemistry and understanding of drug substance development, process chemistry, pharmaceutical manufacturing, and their link to analytical development.
Vertex is seeking an experienced scientist to develop cutting-edge small molecules and the analytical control science underpinning their syntheses as part of the Drug Substance Control Strategy team in Analytical Development.
Key Duties and Responsibilities:
- Collaboratively design and oversee drug substance process development analytical activities across all phases, including late phase development following Quality by Design (QbD) principles.
- Set and justify specifications for drug substance, intermediates, and starting materials, considering clinical study design, toxicology support, CMC processes, and regulatory guidelines.
- Identify critical in-process-control (IPC) issues and develop appropriate IPC methods.
- Serve as subject matter expert for drug substance analytical development with contract manufacturing and testing labs.
- Develop analytical methods suitable for progressive stages of pharmaceutical development.
- Justify retest period, storage, and shipping conditions for starting materials and intermediates.
- Understand chemical development and solid-state development to identify and document critical factors impacting quality and method performance.
- Develop and review source documents for regulatory submissions.
- Present to cross-functional teams and communicate analytical issues and solutions.
Knowledge and Skills:
- Excellent verbal and written communication.
- Control strategy development experience; spike/purge studies; drug substance QbD process development.
- Working knowledge of cGMP, ICH, FDA, and USP guidelines, including impurity control and nitrosamines.
- Modern small-molecule analytical skills, particularly chromatography.
- Ability to work independently and in a team/matrix environment; manage multiple projects in a fast-paced setting.
Education and Experience:
- Ph.D. with 4+ years analytical development experience (small molecule drug substances). MS (7+ years) or BS (10+ years) also considered.
- Background in modern synthetic organic chemistry and understanding of drug substance development, process chemistry, pharmaceutical manufacturing, and their link to analytical development.