Director, CMC Analytical Chemistry

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

Seniority level

Director

Employment type

Full-time

Job function

Manufacturing and Research

Industries

Biotechnology and Pharmaceutical Manufacturing

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