Director, CMC Analytical Chemistry

2 weeks ago

Boston MA, United States Sionna Therapeutics Full time

Join to apply for the Director, CMC Analytical Chemistry role at Sionna Therapeutics This range is provided by Sionna Therapeutics. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $200,000.00/yr - $235,000.00/yr Position Summary Sionna Therapeutics is seeking a Director of Analytical Chemistry to join their CMC group. The individual must be well versed in modern analytical methods and possess expert knowledge in ICH and regulatory guidance for developing and validating methods to analyze small molecule drug substance and drug products. The position is remote work with occasional in-person meetings in the greater Boston area, as needed. Willingness and ability to travel occasionally (both domestic and international) to manage and audit partner CDMOs is required. This position reports to the Senior Vice President, CMC. Responsibilities Qualify and manage CDMO partners for testing and release of starting materials, drug substance intermediates, API, drug products intermediates and final drug product to support Sionna clinical studies. Work with internal and external partners to lead, develop and assign in-process / release specifications, and serve as analytical point of contact during manufacturing activities. Work with partner teams to develop phase appropriate methods, including validation criteria for release of starting materials, drug substance intermediates, API, drug products intermediates, and final drug product. Manage development and ICH stability studies for Sionna assets, including drug substances, drug products, and any materials as appropriate. Manage technical transfer of analytical methods and stability studies to and between CDMO partners. Develop and champion analytical control strategy including registration/validation plans for Sionna assets and impurity trending for Drug Substance and Drug Products batches. Work with pre-clinical and clinical groups and partners to develop and validate phase appropriate bioanalytical methods for use in Sionna clinical studies. Coordinate CMC analytical activities with internal stakeholders (i.e., Discovery, Toxicology, Quality, Regulatory and Clinical) and external consultants. Author and provide technical review of reports and regulatory documents for US and ex-US filings. Ensure the supporting documents are developed in a timely manner. Qualifications PhD in Chemistry (or) relevant discipline with 8+ years of small molecule analytical research and development experience, or MS with 10+ years of experience. Extensive experience managing CDMOs manufacturing and release of GMP small molecules. Strong project management skills and experience working with external CDMOs. Expert knowledge of regulatory CMC documents relevant to analytical research and development (e.g., ICH Q7, M7, Q1A, Q1E, Q2, Q3A, Q3C, Q3D). Working knowledge of other functions and links to CMC, for example Regulatory CMC, Toxicology, Quality, and Clinical. Outstanding verbal and written communication and collaboration skills within and among cross-functional teams and external organizations. Ability to prioritize duties, manage multiple projects, and make decisions with limited supervision. Seniority level Director Employment type Full-time Job function Manufacturing and Research Industries Biotechnology and Pharmaceutical Manufacturing #J-18808-Ljbffr

  • Director, CMC Analytical Chemistry

    2 weeks ago

    Boston, United States Sionna Therapeutics Full time

    Join to apply for the Director, CMC Analytical Chemistry role at Sionna TherapeuticsThis range is provided by Sionna Therapeutics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$200,000.00/yr - $235,000.00/yrPosition SummarySionna Therapeutics is seeking a Director of Analytical Chemistry...

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