Principal Scientist, CMC Analytical Development
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.
Position Summary:
Sionna Therapeutics is seeking a Principal Analytical Scientist 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. Willingness and ability to travel occasionally (both domestic and international) to manage partner CDMOs is required.
Responsibilities:
- Work with 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 as 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 transfer of analytical methods between CDMO partners.
- Manage stability studies for Sionna drug substances and drug products (experience with H&A Scientific SLIM a plus).
- Coordinate CMC analytical activities with internal stakeholders (i.e., Discovery, Toxicology, Quality, Regulatory and Clinical) and external consultants.
- Complete technical review of reports and regulatory documents for US and ex-US filings.
Qualifications:
- PhD in Chemistry or relevant discipline with 5+ years of small molecule analytical research and development experience, or MS with 10+ years of experience.
- Significant experience working CDMOs for the manufacturing and release of GMP small molecule DS and DP.
- Strong knowledge of regulatory CMC guidance documents relevant to analytical research and development (e.g. ICH Q7, M7, Q1A, Q1E, Q2, Q3A, Q3C, Q3D).
- Expert knowledge of compendia (e.g., USP, EP, BP, etc.).
- 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 with limited supervision.
Salary Range: $170,000 – $190,000
