About the role
The incumbent will 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 required for release and characterization of cGMP live viral drug products at contract laboratories. The primary focus will be development of second-generation release and stability methods but will also include a wide variety of analytical characterization methods such as liquid chromatography and AF4, mass spectrometry, viral cytometry, capillary electrophoresis, and deep sequencing. In addition, the individual will be responsible for developing and overseeing the execution of viral and excipient study protocols to support product licensure, analytical transfers, and troubleshooting at a wide range of external contract vendors.
Location: Remote
Essential Functions
- Manages, oversees, helps design and review method transfer, method development, and validation of release and stability-indicating methods for live viral drug products and assists in the development of analytical validation and verification protocols and associated reports with external contract and consulting SMEs.
- Mentors and trains others on a wide variety of analytical techniques including, but not necessarily limited to cell-based bioassays, viral titer assays, ELISA, dd/qPCR methods, deep sequencing, high-performance liquid chromatography (HPLC/UPLC), mass spectrometry, UV/Vis spectroscopy, and other general molecular biology, virology and cell culture methods.
- Troubleshoots and optimizes analytical methods for the characterization of drug products, standards, and process intermediates. Designs qualification/validation and bridging/comparability studies for product characterization, process clearance, and stability assessments.
- Conducts data analytics, including retrospective data collection and statistical analyses, to support method development, troubleshooting, investigations, and validation efforts.
- Communicates results both internally and externally through oral and written updates, presentations, and formal reports, as necessary. Lead discussions with contractors and clients on technical topics relating to their projects as needed. Acts as key technical point-of-contact (SME) for work under their supervision.
- Exercises technical discretion and critical thinking in the design and interpretation of experiments and experimental reports independently without direct supervisory assistance or guidance.
- Creates and/or revises new department-wide and site-wide procedures and company policy SOPs.
- Collaborates with Quality Assurance, Quality Control, and Regulatory Affairs on analytical method and report reviews, validation, and regulatory submission & compliance issues. Familiarity with current GMP regulations is required.
- Stays abreast of current scientific technologies and regulations related to the manufacture and characterization of live viral products, vaccines, and biologics.
- Proactively communicates strategy to the Analytical/QA teams and work closely with contractors to generate new proposals, work scopes, or change orders, as appropriate. Will support the business aspects of their position by working with their supervisor to review billing/invoicing communications for all work under their supervision.
- Generates and reviews regulatory and client-requested documentation for CMC analytics and product characterization.
- Conducts routine release and stability test report reviews and leads out-of-specification (OOS), out-of-trend, and other event investigations, as needed.
Qualifications
- BS, MS, or PhD in physical, chemical, biological, or pharmaceutical science with the associate years of analytical development and validation experience level as noted below
- 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.
Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.
Total Rewards
CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
Well-Being Benefits
In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.
Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.
- 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
CG Oncology is an Equal Opportunity Employer:
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.