Director, CMC Analytical Chemistry
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 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.
Salary Range: $200,000 – $235,000
