Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: Associate Director, Chemistry, Manufacturing, and Controls (CMC) Small Molecules

Location: Remote US-Based

Essential Functions:

• Act as subject matter expert (SME) on small molecule drug substance and drug product.
•  Write or review manufacturing batch records, protocols and reports related to drug substances and drug product.
• Provide oversight of manufacturing and related activities for cGMP drug substance manufacturing of small molecule drug substance and drug product at CMOs
• Contribute to the review of specifications and in-process controls.
• Sound understanding of analytical methods applicable to small molecules.
• Supervise the execution of activities related process and cleaning validation at CMOs.
• Troubleshoot technical issues, analyze data, identify solutions, and propose recommendations.
• Support coordination of production schedules based on clinical and commercial requirements.
• Write and or review regulatory submission modules and any other documents to support submission and product approval.
• Work and communicate effectively with internal or external stakeholders.
• Independently lead major project tasks, manage timelines and escalate issues as needed
• Ensure that CMC documentation is complete, well organized, scientifically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews
• Provides clear and concise communications and instructions to partner CMOs for development and manufacturing activities.
• Small molecule manufacturing representative in cross-functional working teams, and responsible for communicating drug substance and drug product related issues and information to relevant groups within the company

Qualifications:

• BSc or MSc in chemistry, pharmaceutical sciences, or related discipline within pharmaceutical sciences.
• 8+ years of experience in small molecule drug substance and drug product development
• Strong synthetic organic chemistry knowledge and problem solving skills.
• Strong understanding of small molecule processes and products
• Direct experience working with CMOs.
• In depth understanding and knowledge of industry practices in drug substance manufacturing and supply
• Sound knowledge of cGMP regulations and compliance
• Good understanding of analytical methods and related issues
• Experience in writing and reviewing CMC sections for Regulatory submissions.
• Strong understanding of drug development process from R&D through commercialization
• Strong written and verbal communication skills
• Strong organizational skills and ability to effectively manage multiple priorities and projects.

The U.S. target annual salary range for this remote, full-time, position is currently set at $170,000 - $183,000. The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

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 most 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 – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• 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.

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.