Principal Scientist – Analytical Development
| Company | Vertex Pharmaceuticals |
|---|---|
| Location | Boston, MA, USA |
| Salary | $136000 – $204000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior |
Requirements
- Excellent verbal and written communication skills are essential.
- Experience and/or working knowledge of control strategy development, spike / purge studies, drug substance QbD process development
- Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / *in silico* control), and nitrosamines)
- Skilled in modern analyses for peptides, oligonucleotides, and/or small molecule pharmaceuticals, particularly chromatography.
- The ability to work successfully in both a team/matrix environment as well as independently
- The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects
- Ph.D. with 4-7 years of relevant analytical development experience, particularly focused on development of novel drug substances. Exceptional candidates with MS or BS degrees and extensive high-level experience will also be considered.
- Background in, or good understanding of modern synthetic organic chemistry, as well as of the drug substance development process, process chemistry, and pharmaceutical manufacturing, and their interrelationship with analytical development.
- Hands-on experience in the analysis and familiarity with the control strategy of synthetic peptide and oligonucleotide-based pharmaceuticals.
Responsibilities
- Collaboratively design and oversee drug substance process development analytical activities across all phases of development, including late phase development following Quality by Design (QbD) principles
- Serves as subject matter expert for setting and justifying drug substance, intermediates, and starting materials specifications with the understanding of clinical study design, supporting toxicology studies, and CMC processes
- Identify critical in-process-control issues and develop appropriate IPC methods
- Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs
- Develop analytical methods, suitable for progressive stages of pharmaceutical development and/or supervise activities
- Justify and set retest period, storage, and shipping conditions for starting materials and intermediates
- Understand chemical development and solid-state development to identify and document critical factors that impact method performance and/or analytical development activities
- Develop and review source documents for regulatory submissions
- Present to cross functional teams and effectively communicate critical analytical issues and solutions
Preferred Qualifications
- Exceptional candidates with MS or BS degrees and extensive high-level experience will also be considered.