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Scientist, Drug Product
Location:
Irvine, CA
Description:
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: Scientist, Drug Product Location: Remote US-Based Full Time Essential Functions: Oversee sterile drug product manufacturing activities and lead process characterization studies to understand and define CPPs and CMAs of manufacturing processes for novel bladder cancer therapies. Design and execute drug product process performance qualification (PPQ) protocols to demonstrate the robustness and reproducibility of manufacturing processes, ensuring consistent product quality and regulatory compliance. Coordinate completion of documentation including document review and approval and change records to ensure manufacturing readiness and supply availability. Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, Supply, and Regulatory Affairs, to define PC/PPQ strategies and manufacturing to ensure alignment with project timelines and objectives. Analyze data from PC/PPQ studies and generate comprehensive reports, summarizing key findings, conclusions, recommendations for process optimization and control, and author sections of regulatory filings. Develop and implement statistical approaches for data analysis, including design of experiments (DOE), statistical process control (SPC), and multivariate analysis (MVA), to assess process performance, variability, identify critical process parameters and proactively implement process changes. Provide technical support and troubleshooting expertise ensure successful execution of PC/PPQ protocols and adherence to regulatory requirements. Stay abreast of industry best practices, regulatory guidelines, and emerging trends in process characterization and performance qualification through literature review, participation in scientific conferences, and collaboration with external experts. Qualifications: Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or related field. Three to five years of relevant experience in process characterization, performance qualification, or related areas within the pharmaceutical or biotechnology industry. Technical Proficiency: Proficiency in statistical analysis software (e.g., JMP, Minitab) and Microsoft Office suite. Strong understanding of sterile drug product manufacturing processes Familiarity with FDA and ICH guidelines for process validation and qualification activities Understanding of cGMP regulations Experience working with CDMOs The U.S. target annual salary range for this remote, full-time, position is currently set at $145,000 - $158,000. 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.
Company:
CG Oncology
Posted:
April 30 on AlphaStaff Hiring
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More About this Listing: Scientist, Drug Product
Scientist, Drug Product is a Science & Pharmaceutical Scientist Job at CG Oncology located in Irvine CA. Find other listings like Scientist, Drug Product by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Scientist, Drug Product is a Science & Pharmaceutical Scientist Job at CG Oncology located in Irvine CA. Find other listings like Scientist, Drug Product by searching Oodle for Science & Pharmaceutical Scientist Jobs.