Company: Syros Pharmaceuticals
Post: Senior Scientist, Analytical Development
Location: Cambridge
Responsibilities:
- Manage and oversee analytical activities of drug substance and drug product development for assigned Syros clinical assets
- Design, plan and execute analytical experiments and interpret results
- Establish specifications and stability protocols that meet relevant regulatory requirements
- Collaborate with CMOs/CROs for all analytical activities including method development, method validation, process/formulation related analytical support, reference standards, release, and stability testing
- Develop, review, and approve analytical source documents for GMP and regulatory submissions
- Author analytical sections for regulatory submissions
- Collaborate with process chemistry, drug product, quality assurance, CMC regulatory, and CMC project management for all analytical plans
- Effectively represent all analytical development activities at internal and external meetings
Success Factors
- Ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects
- Excellent written and verbal communication skills
- Results driven with attention to time and budget
- Willingness to learn while actively contributing to drug development
- Sense of urgency
- Acts with integrity and respect always
Job Requirements
- PhD (or Postdoc) with a minimum of 5 years of analytical chemistry experience in a pharmaceutical or biotechnology role or a Master's or Bachelor’s degree with a minimum of 12 years of relevant work experience
- Well-versed in common techniques used in the pharmaceutical industry, such as HPLC, GC, KF, dissolution, and spectroscopy, including both theory and practice
- Experience in analytical method development and validation, establishing specifications, and managing stability data
- Proven ability to build and maintain vendor relationships
- Ability to travel as needed to support manufacturing campaigns, among other activities (when deemed safe from COVID by appropriate authorities)
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