Associate Director, Chemistry Manufacturing Controls
2 weeks ago
Job 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 various cross-functional teams and ensures all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial products. This role may supervise other regulatory staff.Key Duties and Responsibilities:•Leads the preparation and review of CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies•Develops global CMC regulatory strategies for one or more investigational and/or marketed products•Leads regulatory colleagues in development of global CMC regulatory strategies and submissions•Provides CMC regulatory guidance to cross-functional teams and key stakeholders•Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations•Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects•Participates in the design, development and implementation of department strategies, providing recommendations in area of expertiseKnowledge and Skills:•Excellent interpersonal skills to communicate difficult concepts and persuade others•Strategic thinking and strong problem solving skills•Collaborates and communicates in an open, clear, complete, timely, and consistent manner•Strong sense of planning and prioritization, and the ability to work with all levels of management•Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelinesEducation and Experience:Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science fieldTypically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experienceWe’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility.
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Boston, Massachusetts, United States Kernal Biologics Full time $200,000 - $300,000 per yearVP 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 and blood cancers. The company was founded by experts from MIT,...
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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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Director, CMC Analytical Chemistry
2 weeks ago
Boston, United States Sionna Therapeutics Full timeJoin 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...
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Boston, United States Takeda Full timeDescription Associate Director, Digital Product Stewardship – ChemistryPosition SummaryWe are seeking a strategic and hands-on Associate Director to lead digital product stewardship for chemistry-related data and workflows across the Aedifica Fortis (AF) portfolio. This role will serve as a critical bridge between medicinal chemistry teams, digital product...
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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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Director, Medicinal Chemistry
2 weeks ago
Boston, United States HotSpot Therapeutics, Inc Full timeFull-time, hybrid role based in Boston, MA At HotSpot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – called regulatory hotspots – that can be exploited through small molecule drug discovery. Regulatory...
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Director, Medicinal Chemistry
7 days ago
Boston, United States HotSpot Therapeutics, Inc Full timeFull-time, hybrid role based in Boston, MAApply (by clicking the relevant button) after checking through all the related job information below.At HotSpot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – called...
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Associate Director, Computational Chemistry
3 weeks ago
Boston, MA, United States BioSpace Full timeAssociate Director, Computational Chemistry Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck. At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic...
