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Sionna Therapeutics · 1 week ago

Principal Scientist, CMC Drug Substance

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 revolutionizing treatments for cystic fibrosis (CF). They are seeking a Principal Scientist to lead drug substance development and manufacturing, providing technical expertise in synthetic methodology and process optimization.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Responsibilities

Design, develop, and optimize robust, cost-effective synthetic routes to drug substance, drug substance intermediates and starting materials, with a focus on step reduction, convergence, scalability, efficiency and sustainability

Provide subject-matter expertise in synthetic organic chemistry and process development to support programs from preclinical through registration

Contribute to the development and execution of control strategies (RSM, Impurities etc.,) in alignment with global regulatory expectations

Support the qualification, technical oversight, and ongoing management of CDMOs manufacturing and releasing Sionna products

Lead and support manufacturing campaigns for Sionna products at external CDMOs

Participate in technical transfers, process troubleshooting, and manufacturing investigations at partner sites

Contribute to Quality-by-Design (QbD) activities for late-stage development, including risk assessments, identification of critical quality attributes (CQAs), and establishment of control strategies

Support process engineering, scale-up, and process safety studies in collaboration with internal and external experts

Assist with analytical method development, qualification, and validation strategies as they relate to stage appropriate drug substance development and manufacturing

Author and/or technically review in-process and release specifications, analytical methods, stability protocols, and master batch records

Contribute to the preparation and technical review of CMC sections of regulatory submissions for US and ex-US filings

Ensure activities are aligned with relevant regulatory guidance (e.g., ICH Q7, ICH Q11)

Work closely with internal stakeholders including Discovery, Analytical Chemistry, Quality, Regulatory CMC, and Clinical teams

Collaborate effectively with external consultants and manufacturing partners to ensure alignment on technical and program objectives

Qualification

Organic ChemistrySmall Molecule DevelopmentSynthetic MethodologyRegulatory CMC KnowledgeTechnical Problem-SolvingCommunication SkillsOrganizational Skills

Required

PhD in Organic Chemistry or relevant discipline with 5+ years of small molecule drug substance and development experience, or MS with 10+ years of relevant experience

Demonstrated experience in novel route design, development, and optimization for small molecule Starting Materials

Hands-on experience supporting or leading CDMO execution and release of kilogram-scale batches

Strong technical problem-solving skills with the ability to work independently on complex chemistry challenges

Working knowledge of regulatory CMC requirements and Regulatory guidance (ICH)

Experience collaborating across CMC-related functions such as Quality, Regulatory, and Clinical

Excellent written and verbal communication skills, with the ability to clearly convey technical concepts to diverse audiences

Strong organizational skills with the ability to prioritize duties and manage multiple projects with limited supervision

Must be willing to travel domestically and internationally as required