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Director, CMC, Analytical

Sionna Therapeutics is a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF) by normalizing the function of CFTR, the key protein associated with disease progression in CF. Building on over a decade of extensive research on the genetic mutations associated with CF and founded in 2019, Sionna is advancing a pipeline of small molecules engineered to correct the protein defects caused by ΔF508, the most common mutation that affects the CFTR protein. The company has a first-in-class portfolio of programs targeting correction of NBD1, the key and unique mechanism to enable full restoration of ΔF508-CFTR function, and complementary programs targeting ICL4 and TMD1. Sionna’s pipeline has the potential to deliver best-in-class efficacy and reach previously unachievable levels of long-term benefit for people with CF.

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 Vice President, CMC.

We are accepting resumes for the position at careers@sionnatx.com.

Key Responsibilities:

  • Qualification and management of 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 develop and assign in-process / release specifications, and act of analytical point of contact during manufacturing activities.
  • Work with partner teams to develop phase appropriate methods including validation/qualification for release starting materials, drug substance intermediates, API, drug products intermediates and final drug product.
  • Manage development and ICH stability studies for Sionna drug substances and drug products.
  • Manage technical transfer of analytical methods and stability studies between CDMO partners.
  • Develop and champion analytical validation plans for Sionna assets and correlate impurities across batches of Drug Substance and Drug Products batches.
  • Work with clinical group 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 technical review of reports and regulatory documents for US and ex-US filings.

Minimum Qualifications:

  • PhD in Chemistry with 5+ 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.
  • Able to prioritize duties, manage multiple projects and make decisions with limited supervision.
  • Must have a valid passport and be able and willing to travel domestically and internationally.