Sionna Therapeutics
Principal Scientist, CMC Analytical Development
Sionna Therapeutics, Boston, Massachusetts, us, 02298
Principal Scientist, CMC Analytical Development
Pay range: $170,000 – $190,000 per year.
Sionna Therapeutics is a clinical‑stage biopharmaceutical company on a mission to revolutionize the treatment paradigm for cystic fibrosis by developing novel medicines that normalize CFTR protein function. The company focuses on stabilizing CFTR’s nucleotide‑binding domain 1 (NBD1) to unlock meaningful clinical outcomes. Leveraging a decade of research, Sionna advances a pipeline of small molecules designed to correct the F508del mutation and complementary CFTR modulators that synergize with its NBD1 stabilizers.
Position Summary:
Sionna Therapeutics seeks a Principal Analytical Scientist for its CMC group. The candidate must have expertise in modern analytical methods and deep knowledge of ICH and regulatory guidance for developing and validating methods to analyze small‑molecule drug substance and products. Frequent travel (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 product intermediates, and final drug product to support Sionna clinical studies.
Collaborate with internal and external partners to develop and assign in‑process/release specifications, acting as analytical point of contact during manufacturing activities.
Develop phase‑appropriate methods, including validation/qualification for release of starting materials, drug substance intermediates, API, drug product intermediates, and final drug product; manage transfer of analytical methods between CDMO partners.
Manage stability studies for Sionna drug substances and products (experience with H&A Scientific SLIM a plus).
Coordinate CMC analytical activities with internal stakeholders (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 R&D experience, or MS with 10+ years of experience.
Significant experience working with CDMOs for the manufacturing and release of GMP small‑molecule DS and DP.
Strong knowledge of regulatory CMC guidance documents relevant to analytical R&D (e.g., ICH Q7, Q1A, Q1E, Q2, Q3A, Q3C, Q3D).
Expert knowledge of compendia (e.g., USP, EP, BP).
Working knowledge of other CMC functions and their links to analytical work (Regulatory CMC, Toxicology, Quality, Clinical).
Outstanding verbal and written communication and collaboration skills within and among cross‑functional teams and external organizations.
Ability to prioritize duties and manage multiple projects with limited supervision.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Research and Manufacturing; Biotechnology and Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid paternity leave
Paid maternity leave
Disability insurance
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Sionna Therapeutics is a clinical‑stage biopharmaceutical company on a mission to revolutionize the treatment paradigm for cystic fibrosis by developing novel medicines that normalize CFTR protein function. The company focuses on stabilizing CFTR’s nucleotide‑binding domain 1 (NBD1) to unlock meaningful clinical outcomes. Leveraging a decade of research, Sionna advances a pipeline of small molecules designed to correct the F508del mutation and complementary CFTR modulators that synergize with its NBD1 stabilizers.
Position Summary:
Sionna Therapeutics seeks a Principal Analytical Scientist for its CMC group. The candidate must have expertise in modern analytical methods and deep knowledge of ICH and regulatory guidance for developing and validating methods to analyze small‑molecule drug substance and products. Frequent travel (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 product intermediates, and final drug product to support Sionna clinical studies.
Collaborate with internal and external partners to develop and assign in‑process/release specifications, acting as analytical point of contact during manufacturing activities.
Develop phase‑appropriate methods, including validation/qualification for release of starting materials, drug substance intermediates, API, drug product intermediates, and final drug product; manage transfer of analytical methods between CDMO partners.
Manage stability studies for Sionna drug substances and products (experience with H&A Scientific SLIM a plus).
Coordinate CMC analytical activities with internal stakeholders (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 R&D experience, or MS with 10+ years of experience.
Significant experience working with CDMOs for the manufacturing and release of GMP small‑molecule DS and DP.
Strong knowledge of regulatory CMC guidance documents relevant to analytical R&D (e.g., ICH Q7, Q1A, Q1E, Q2, Q3A, Q3C, Q3D).
Expert knowledge of compendia (e.g., USP, EP, BP).
Working knowledge of other CMC functions and their links to analytical work (Regulatory CMC, Toxicology, Quality, Clinical).
Outstanding verbal and written communication and collaboration skills within and among cross‑functional teams and external organizations.
Ability to prioritize duties and manage multiple projects with limited supervision.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Research and Manufacturing; Biotechnology and Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid paternity leave
Paid maternity leave
Disability insurance
#J-18808-Ljbffr