Log In
Sign Up
Responsibilities
- Develop novel analytical method for long-acting injectable product hands-on at internal CMC lab
- Lead and oversee CRO/CDMO partnerships in developing and validating analytical methods
- Develop and implement phase-appropriate quality control strategy for drug substances and products
- Manage product stability study programs to ensure compliance and efficacy
- Author analytical development and validation reports and sections for IND and NDA filings
- Collaborate with QA, Regulatory, and other CMC functions to address safety-related questions
- Serve as the CMC representative on cross-functional project teams for alignment and integration
Requirements
- PhD in Analytical Chemistry or related field with 10+ years of experience
- Desire to develop novel analytical methods at internal CMC lab for long-acting injectable product
- Proven track record of developing analytical methods and managing CROs/CDMOs
- Extensive experience drafting analytical sections of INDs and NDAs
- Demonstrated ability to draft, review, and submit documentation in compliance with cGMP and GLP
- Strong background in implementing phase-appropriate quality control strategies
- Excellent scientific knowledge in analytical and organic chemistry
- Proficient in analytical method development and validation
- Comprehensive knowledge of quality control strategies for drug substances and products
- Effective verbal and written communication skills
- Proven ability to work successfully in cross-functional teams
Benefits
- Highly competitive and inclusive medical, dental, and vision coverage options
- BCBS PPO and PPO HSA plans
- BCBS Dental Plan
- EyeMed Vision Plan
- FSA and HSA for medical and dependent care expenses
- 401(k) Program with company match
- Corporate Wellness Program
- Unlimited Paid Time Off policy
- Winter shut down
- 12 weeks 100% paid parental leave for birthing/primary parent and primary guardian
- 3 weeks 100% paid parental leave for non-birthing/non-primary parent/guardian
- Paid Life, LTD, and STD insurance coverages, plus voluntary benefit options
- Free parking, subsidized commuter passes, or $100 monthly stipend for walking/biking to work
- Company lunches on Wednesdays
