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Sionna Therapeutics · 9 hours ago

Principal Scientist, CMC Analytical Development

Waltham,MA,US

Full-time

Hybrid

Senior Level, Lead/Staff

$170K/yr - $190K/yr

5+ years exp

Sionna Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel medicines for cystic fibrosis. They are seeking a Principal Analytical Scientist to lead CMC analytical activities, manage relationships with CDMO partners, and ensure compliance with regulatory guidelines for small molecule drug development.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

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

Qualification

PhD in ChemistrySmall molecule analytical researchRegulatory CMC guidanceGMP small molecule experienceCompendia knowledgeCommunication skillsCollaboration skillsProject management

Required

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