Senior Manager, Analytical Development
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Job Description
Senior Manager leading analytical development and validation for late-stage live viral projects at CG Oncology. Focus on commercialization and analytical methodologies to improve patient outcomes in oncology.
Responsibilities:
- Lead projects or act as a subject matter expert (SME) under minimal supervision focused on the late-stage and commercial development, validation, and optimization of analytical methods
- Manages, oversees, helps design and review method transfer, method development, and validation of release and stability-indicating methods
- Mentors and trains others on a wide variety of analytical techniques
- Troubleshoots and optimizes analytical methods for the characterization of drug products
- Designs qualification/validation and bridging/comparability studies for product characterization
- Conducts data analytics, including retrospective data collection and statistical analyses
- Communicates results both internally and externally through oral and written updates
Requirements:
- BS, MS, or PhD in physical, chemical, biological, or pharmaceutical science
- BS plus eight (8) years of experience, or MS plus six (6) years of experience, or PhD plus three (3) years of experience
- Experience with analytical development and qualification/validation of biologics, especially live viral products
- Experience with late-Phase and commercial bio-analytics
- Knowledge of OFAT, DOE, and other study design methodologies including experience with statistical analyses
Benefits:
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2025 we will observe 14 holidays
- RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
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