Associate Director/Director Pharmaceutical Development
Benefits
Unlimited PTO
Similar Jobs
See allSenior Manager/Associate Director, CMC Regulatory Affairs
Erasca
US
Regulatory Affairs
CMC
Oncology
Director, Regulatory Affairs, CMC
BrainChild Bio
US
Cell Therapy
FDA Regulations
GMP
Senior Director, Clinical Pharmacology
Amylyx
US
Regulatory Submissions
Cross-functional Collaboration
Director, CMC Regulatory Affairs
Jade Biosciences
US
Regulatory Affairs
CMC
Cross-functional Collaboration
Director, CMC Regulatory Affairs
Recursion
UK
Regulatory Affairs
CMC
GMP
What You'll Do:
- Provide strategic pharmaceutical development guidance as CMC lead to cross functional project teams.
- Develop robust formulations and manufacturing processes to support development and rapid registration.
- Review development and manufacturing programs at CROs to ensure compliance with quality standards.
Responsibilities:
- Ability to work effectively and collaboratively on cross functional project teams in a fast-paced dynamic environment.
- Develop complex formulations for pediatric indications and work effectively with CDMOs.
- Hands-on experience in clinical trials management, formulation development, and clinical trial manufacturing.
Who You Are:
- PhD or advanced degree in Chemistry or Pharmacy with 7+ years of industry experience.
- Expertise in formulation, knowledge of PK/PD principles, ADME concepts, and regulatory documentation.
- In-depth knowledge of CMC Regulatory requirements for US and EU.
BridgeBio
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.