Director, CMC Analytical Development

We are seeking a passionate CMC analytical lead to be responsible for the development, validation and transfer of analytical methods and characterizations of drug substances, drug products and process intermediates of oligonucleotide therapeutic modality to support City's development goals. The Director of CMC Analytical will be championing a program working with external and internal partners for the next generation siRNA development candidates.

Main responsibilities

• Collaborate with Drug Substance, Drug Product and Quality Assurance to ensure strong cross functional collaborations and serve the analytical functional line to ensure the technical / project timelines and milestones.
• Oversee efficient and effective development, utilization, and transfer of optimized analytical methods and associated specifications for drug substances and/or drug products that meet or exceed the current regulatory expectations and that ensure the high and consistent quality and performance of drug substances and drug products.
• Author and review product specifications and specification justifications
• Author and review DS/DP documentation including, but not limited to, method development reports, method validation protocols/reports, release and stability testing reports, comparability and batch analysis reports.
• Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies and executions
• Author and review high-quality CMC packages for submissions.
• Ensure the team meets agreed performance, throughput and quality targets and that resourcing is aligned to R&D priorities.
• Provide analytical guidance and support for internal oligo production team

Qualifications:

• B.S., M.S., or Ph.D. degree in analytical chemistry, chemistry, or biochemistry. or related degrees with the following pharmaceutical industry experience
• 15+ years with a B.S degree
• 12+ years with a M.S. degree
• 10+ years with a Ph.D. degree
• Extensive experience in analytical method development (esp. HPLC-MS, MS/MS) including characterization methodologies for drug substance and drug product, validation and transfer.
• Extensive experience in trend data analysis for stability programs.
• Experience in building and managing relationships with 3rd parties and leading virtual CMC teams to deliver analytical control strategies for drug substances and drug products.
• Experience in working with oligonucleotides methodologies and strategies in a highly matrixed environment.
• Experience in managing, coaching, mentoring and developing analytical scientists.
• Experience in early and or late stage drug development and regulatory filings
• Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
• Experience across multiple therapeutic modalities (small molecules, oligonucleotides, peptides and large molecules) is a plus
• Experience in drug product formulation development is a plus
• Excellent communication and organization skills and a great team player required

City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency submissions will not be accepted at this time.

City Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.