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
Job Description We are looking for an experienced Regulatory Business Analyst with strong expertise in Veeva Vault RIM, regulatory data management, and business process optimization to support Global Regulatory Affairs technology initiatives. The ideal candidate will
Imagine yourself… Growing your expertiseand expanding your skillset with every project. Thriving in a supportive team environmentthat inspires you to strive for excellence. Contributing to a brighter, more sustainable future. At Hach (www.hach.com), a Veralto company,
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
General Information Job Advert Title: 【つくば】分析開発サイエンティスト・外部製造技術統括（SME） Location: Tokodai, Ibaraki Division: External Manufacturing Employment Class: Permanent Description Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies
At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create,
About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century. Antheia’s commercially proven technology platform produces high-value pharmaceutical ingredients in a fraction of the time compared to legacy approaches
Job Description General Summary: The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, will be responsible for providing scientific and technical expertise within and across functional areas for late-stage & commercial methods and vendor
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress
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”
Coding Integrity Coordinator/Educator Position Summary The Coding Integrity Coordinator is responsible for monitoring and performing audits on inpatient or outpatient coded data for accuracy based on documentation in the medical record and through these audits will
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