Director, CMC Analytical Chemistry
2 weeks ago
Join to apply for the Director, CMC Analytical Chemistry role at Sionna TherapeuticsThis range is provided by Sionna Therapeutics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$200,000.00/yr - $235,000.00/yrPosition SummarySionna 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.ResponsibilitiesQualify 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.QualificationsPhD 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.Seniority levelDirectorEmployment typeFull-timeJob functionManufacturing and ResearchIndustriesBiotechnology and Pharmaceutical Manufacturing #J-18808-Ljbffr
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Director, CMC Analytical Chemistry
2 weeks ago
Boston, MA, United States Sionna Therapeutics Full timeJoin to apply for the Director, CMC Analytical Chemistry role at Sionna Therapeutics This range is provided by Sionna Therapeutics. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $200,000.00/yr - $235,000.00/yr Position Summary Sionna Therapeutics is seeking a Director of Analytical...
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Boston, United States Kernal Biologics, Inc. Full timeVice President of Chemistry Manufacturing and Controls (VP of CMC)VP of CMCAbout Kernal Biologics, Inc.Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases...
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Boston, MA, United States Kernal Biologics, Inc. Full timeVice President of Chemistry Manufacturing and Controls (VP of CMC) VP of CMC About Kernal Biologics, Inc. Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune...
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Boston, MA, United States Kernal Biologics Full timeVice President of Chemistry Manufacturing and Controls (VP of CMC) About Kernal Biologics, Inc. Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and...
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Associate Director, Analytical Development
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Boston, United States Stratacuity: Proven Scientific Placement Full timeAssociate Director, Analytical Development Our client is seeking an accomplished leader to join our team as Associate Director, Analytical Development (Small Molecules). This role will drive analytical strategy and execution for late-phase development programs, ensuring robust data packages to support NDA submissions and eventual commercialization. The ideal...
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Associate Director CMC, Drug Product 2064423
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Boston, United States Stratacuity: Proven Scientific Placement Full timeAssociate Director CMC, Drug Product 2064423Job Overview: Seeking a Manager/Senior Manager, CMC, Drug Product to oversee small molecule drug development, manage outsourced development activities, and handle cGMP manufacturing campaigns.Primary Job Responsibilities:Lead CMC drug product projects, including development, optimization, and manufacturing at...
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Associate Director, Analytical Development
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Boston, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time $120,000 - $180,000 per yearAssociate Director, Analytical DevelopmentOur client is seeking an accomplished leader to join our team as Associate Director, Analytical Development (Small Molecules). This role will drive analytical strategy and execution for late-phase development programs, ensuring robust data packages to support NDA submissions and eventual commercialization. The ideal...
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Director, Global Regulatory Affairs CMC
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Boston, United States Boston Staffing Full timeGRA Chemistry Manufacturing & Controls (CMC) And Devices Organization RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. This role is within the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's...
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Boston, United States Vertex Full timeJob DescriptionThe Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role also provides regulatory guidance to...
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Boston, United States Dechra Full timeVacancies Associate Director/Director, Biologics CMC Regulatory Affairs Job Introduction This is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on...
