Senior Director - CMC Process Development & MSAT

February 21

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CG Oncology

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CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.

Immuno-Oncology

51 - 200 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• The Senior Director CMC Process Development & MSAT is responsible for the Technology Transfer, process development and scale up of Cretostimogene (AV) drug substance process. • Lead technology transfer team(s) responsible for end-to-end transfer of knowledge, process and technology developed by the CGO technical teams for vector product manufacturing to CGO chosen manufacturing sites. • Troubleshoot manufacturing issues at contract & strategic partners. • Ensure timely support for tech transfer, product/process investigations, training, and improvement projects in collaboration with Technical Operations partners. • Acts as a Subject Matter Expert for the implementation of phase appropriate process development and optimization, manufacturing, and validation activities at external CDMOs by following the FDA guidance and QbD principles. • Reviews Draft, Master, and Executed Batch Records, protocols and reports related to all GMP operations related • Provides technical leadership and communicates clearly and concisely across multiple business functions. • Participates in GMP investigations; develops corrective action plans and implements such plans to resolve process and product issues. • Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high level of cGMP compliance. • Assist in the technical aspects of the company’s regulatory filings, including process validation for the upcoming BLA filing.

🎯 Requirements

• Bachelor’s Degree in relevant/scientific field, or extensive relevant experience in lieu of degree. • Advance degree is preferred. • Minimum of fifteen (15) years of experience in the biopharmaceutical industry. • Work experience with both upstream and downstream aspects of drug substance development and production. • Experience working with or in a contract manufacturing environment with an in-depth knowledge of unit operations for clinical/commercial drug substance and drug products. • Knowledge of drug substance and drug product process development. • Ability to effectively work with external CDMOs to meet the timelines while staying within approved budgets – in a remote or on location capacity. • Ability to effectively work independently in a team environment with the internal department including, but not limited to, the MS&T, Analytical, Regulatory, Clinical Supplies, and Quality Assurance Department in a fast-paced collaborative environment. • Ability to travel up to 25% of the time.

🏖️ 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