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Associate Director/Director of Formulation Development

In the three decades since the discovery of the genetic defects that cause cystic fibrosis (CF), researchers have made remarkable advances for patients. Yet the ultimate goal of CF drug development – to fully normalize the function of CFTR, the key protein leading to the pathology of CF – has remained out of reach. Sionna Therapeutics was formed in late 2019, leveraging 10 years of large pharma scientific investment and expertise. Our experienced scientific team has been on a mission to fully normalize CFTR function, and is developing a portfolio of oral small molecules to accomplish that goal. Our proprietary small molecules correctors bind to the NBD1, ICl4 and TMD1 domains of CFTR and have the potential for best-in-class efficacy. Our first NBD1 corrector, SION-638, began Phase 1 clinical trials in December 2022.

Position Summary

Sionna Therapeutics is seeking an Associate Director/Director of Formulation Development to develop and execute a formulation strategy for our small molecules from pre-clinical through clinical development.  The individual in this role must have the ability to analyze and translate data generated from development and manufacturing activities and execute non-GMP and GMP manufacturing campaign(s).

The position allows for either hybrid or remote work with occasional in-person meetings in the greater Boston area as needed. Willingness and ability to travel domestically and internationally to manage partner CDMO’s and audit potential partner CDMO’s is required. This position reports to the Vice President, CMC.

Key Responsibilities:

  • Develop network of preferred Pre-formulation, Formulation development and Drug Product manufacturing CDMOs
  • Develop Formulation strategy for Sionna small molecules from pre-clinical through Registration
  • Prepare Requests For Proposals (RFP’s) for Pre-formulation, Formulation development and clinical formulations (Suspension, tablets, capsules) and manage RFP review process.
  • Qualification and Management of CDMOs doing pre-formulation, formulation development, and manufacturing/release of cGMP batches of Drug Product.
  • Technical review and authorization of in-process / release specifications, stability studies, master batch records.
  • Manage Formulation Development budget
  • Coordinate CMC activities with internal stakeholders (ie discovery, quality, regulatory, clinical) and external consultants
  • Authoring and technical review of regulatory documents for US and ex-US filings
  • Risk identification, mitigation, and management

Minimum Qualifications:

  • PhD with 10+ years of Formulation Development experience, or MS with 12+ years of experience
  • Demonstrated capabilities developing and executing:
    • Formulations for pre-clinical PK and toxicology studies (non-GLP and GLP)
    • Enabling formulations (suspension and/or compounding) for early clinical development
    • Tablets and capsules for later clinical development
  • Strong program management skills and experience working with external CDMOs required
  • Prior experience in small startup companies preferred
  • Working knowledge and/or experience running registration enabling Drug Product programs
  • Working knowledge of regulatory CMC and related guidance documents
  • Working knowledge of other functions and links to formulation development (analytical, chemistry, quality, clinical)
  • Must have outstanding communication and collaboration skills within cross-functional team and external organizations
  • Able to prioritize duties and manage multiple projects with limited supervision
  • Must have a valid passport and be able and willing to travel domestically and internationally
  • Must have up to date Covid-19 vaccines and boosters