Oligonucleotide CMC Lead Key Responsibilities:
- Lead drug substance / drug product development of oligonucleotides, analytical development, Quality Assurance and oversight of manufacturing process with external CDMO and future inhouse GMP manufacturing facility.
- Author and review technical protocols and reports in support of preclinical (hundred grams scale) and clinical stage (kilo gram scale) manufacture and process characterization activities.
- Contribute to strategic technical discussions and present progress at internal and external scientific meetings.
- Lead the preparation of the Drug Product and analytical section of regulatory filings and effectively represent the CMC function in interactions with regulatory authorities.
- Effectively integrate CMC activities with other functions, including chemistry synthesis, and Regulatory Affairs, and oversight of manufacturing processes.
- Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings.
- Ph.D. with 3+ years or master’s with 6+ years degree in chemistry, chemical engineering, biochemical engineering, or pharmaceutical sciences，with prior industry experience in oligonucleotide or peptide products.
- Hands-on experience in process development and process validation of drug products and dosage forms across multiple development projects including process transfer and management of contract manufacturing.
- Demonstrated management experience of successful drug product process development teams.
- Experience in preparing regulatory documents including briefing documents for regulatory meetings.
- In-depth understanding and hands-on experience in drug product process development, analytical development and Quality Asssurance.
- Hands-on experience in analytical methods for characterization of drug products and processes.
- Excellent leadership, organizational and communication skills.
- Demonstrated strong operational execution and problem-solving skills.
- Eagerness to learn new techniques.
Contact Us: HR@ronatherapeutics.com