Job Description The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy regulatory CMC strategies for marketed products. This role contributes to the planning, preparation and submission of regulatory CMC documentation. This role also
About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the
Regulatory CMC Manager Cell and Gene Therapy Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping
Regulatory Consultant - CMC (CMC with small molecule products) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum,
About Cristcot We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better
Job Summary Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global
Department:106800 Technical Operations Location:San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that
Regulatory Affairs Expert-IND Submission-CMC-Home based-South Korea-ICON Strategic Solutions ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration,
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement.read on In 2015, we pioneered a “moneyball for biotech”
General Information Job Advert Title: Scientist（製剤研究所_注射剤プロセス設計/処方設計） Location: Yaizu, Shizuoka Division: CMC Development Employment Class: Permanent Description 【募集の背景 / Purpose & Scope】 弊社製剤研究所では，バイオ医薬品を始めとした無菌医薬品の製剤開発に取り組んでいます。これらの医薬品開発分野において，無菌製剤の処方設計・プロセス設計の経験を有し，斬新なアイデアとチャレンジ精神，熱意を持って研究を遂行し，プロジェクトをグローバルにリードできる人材を募集します。 【職務の内容 / Essential Job Responsibilities】 （雇入れ直後） 無菌製剤を中心に下記の業務を遂行していただきます。 ・無菌注射製剤の処方設計 ・無菌注射製剤の治験薬並びに商用製造プロセス開発 ・申請業務（IND/IMPD, CTD作成および照会事項対応） ・GMP製造所への製造技術移管 ・商用後の生産課題解決，安定生産支援，変更管理対応 ・製剤開発戦略の立案 ・導入PJにおけるパートナーとの協働
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Building on the knowledge gained in the Oncology field, Kyverna is utilizing proven CAR T
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved
Description Founded in 2007, Initiate Government Solutions (IGS) is a Woman-Owned Small Business and a fully remote IT services provider supporting federal partners nationwide. We deliver innovative Enterprise IT and Health Services solutions with a strong
About Cristcot We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better
AIR’s Healthcare Transformation Program is seeking an experienced Managing Director (MD) to lead and advance a portfolio of Medicaid policy and data analytics initiatives policy priorities., with a focus on strategic growth and innovation. The MD
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The Senior Director, Analytical Development & Quality Control (Small Molecules) provides strategic and operational leadership for all analytical activities supporting drug substance and drug product development, clinical supply, commercial manufacturing, and lifecycle management. This leader is
Job Description Position Summary: The Senior Director, Global Quality Systems holds a pivotal leadership position within the Quality organization. This individual is responsible for providing strategic vision and direction to advance the framework, strengthen organizational capabilities,
If you are a current Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We
Job Description General Summary: At Vertex, we are driven by a shared commitment to transform the lives of patients with serious diseases. The Executive Director, Manufacturing Operations will play a critical leadership role in delivering on