- Job Type: Full-Time
- Function: Manufacturing
- Industry: Oncology
- Post Date: 12/04/2023
- Website: www.cgoncology.com
- Company Address: 400 Spectrum Center Drive, Suite 2040, Irvine, CA, 92618
About CG OncologyOncolytic immunotherapies in bladder cancer
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.
Role: SENIOR MANAGER, CMC PROCESS DEVELOPMENT
Location: Remote US-Based
- The Senior Manager of CMC Process Development will report to the Sr. Director of Process Sciences and execute activities supporting the late-stage development and BLA readiness activities for our lead program, crestostimogene grenadenorepvec (CG0070) through our CDMOs.
- The individual will collaborate on the CMC development plan to monitor the course to BLA and commercialization of CG0070.
- The individual will be responsible to obtain and aggregate information upstream and downstream, monitor performance against KPIs and apprise Technical Operations/CMC leadership of progress and risks through regular communications and periodic reviews throughout development and in support of filings and approvals.
- The individual will remain in close communication with the CDMO and similarly help to address issues, monitor, and facilitate attainment of DS/DP objectives, identify, and recommend how to mitigate process constraints, and ensure progress against strategic and tactical plans.
- Bachelor’s Degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences, or related discipline).
- Eight (8) years of relevant experience in pharmaceutical/biotechnology industry experience in managing CDMOs for the manufacture of non GMP and cGMP DS and DP.
- Experience with projects clinical through Phase 3, BLA and including multiple molecule types (cell and gene therapy experience a plus).
- Strong leadership skills with ability to be hands-on and lead/manage the CMC programs.
- Thorough knowledge of cGMP manufacturing and filings; thorough and relevant knowledge of FDA and EMA regulations.
- Strong skills in identifying and resolving critical issues.
- Strong track record in effectively working with senior management.
The U.S. target annual salary range for this remote, full-time, position is currently set at $165,000 - $175,000. 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.
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
- SPECIAL RECOGNITION
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 up to $300,000 + 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.