Associate Director, Analytical Development
1 week ago
Associate Director, Analytical Development & QC (Boston, MA) The individual will lead the development, implementation, and improvement of internal QC systems for internal teams and external partners. You will proactively manage QC gap analyses and help lead CDMO partnerships on analytical method transfer and phase-appropriate qualification and validation. You will not be siloed, but rather you will be expected to interact across different functional groups and partner collaboratively. Responsibilities Lead and manage, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs. Partner with internal and external teams to meet timelines and company objectives, including, Non-clinical Development, Quality Assurance, Regulatory, and CRO/CDMOs. Proactively manage QC gap analyses and QC SOP authoring and revisions for continuous improvement. Oversee CDMO for analytical method transfer, phase-appropriate qualification/full validation, reference standard generation and qualification, stability program management and quality control related events. Support CDMO as a technical SME for drug intermediates, DS and DP QC testing activities, ensuring all activities are completed according to established timelines and quality standards. Support CDMO with management and communication of stability pulls and ensure stability testing occurs within specified testing windows to establish/extend DS and DP shelf life based on stability data. Coordinate with internal stakeholders to ensure uninterrupted clinical and commercial supplies. Oversee CDMO to manage reference standard and critical reagent programs, including qualification/requalification, inventory, and bridging activities. Partner with CMC technical SMEs, QA and Regulatory to prepare and review QC related sections of IND, IMPD, NDA/MAA and global regulatory submissions. Provide necessary support information for addressing information requests from regulatory agencies. #J-18808-Ljbffr
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Associate Director, Analytical Development
2 weeks ago
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, Analytical Development
5 days ago
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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Boston, United States Stratacuity: Proven Scientific Placement Full timeA leading life sciences recruitment firm is looking for an Associate Director, Analytical Development in Boston, MA. This role will drive the analytical strategy for late-phase development programs and ensure high-quality data packages for NDA submissions. The ideal candidate will hold a Ph.D. or M.S. in a relevant field and have over 10 years of experience...
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Director, Analytical Development
3 weeks ago
Boston, United States Boston Staffing Full timeDirector, Analytical DevelopmentBuild your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our...
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Director, Analytical Development
1 week ago
Boston, MA, United States curiate.co Full timeDirector, Analytical Development in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission...
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Director, Analytical Development
2 weeks ago
Boston, MA, United States curiate.co Full timeDirector, Analytical Development in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission...
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Director, Analytical Development
1 week ago
Boston, MA, United States curiate.co Full timeDirector, Analytical Development in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission...
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Associate Director, Marketing Analytics
2 weeks ago
Boston, United States Boston Staffing Full timeAssociate Director, Marketing Analytics OabSumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of...
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Associate Director, Marketing Analytics
3 weeks ago
Boston, United States Massachusetts Staffing Full timeAssociate Director, Marketing Analytics OabSumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of...
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Boston, United States Vertex Full timeSenior Director, Analytical Development (AD) Biologics and Cell and Gene TherapiesVertex is seeking a talented and experienced leader to join our Analytical Development (AD) Biologics and Cell and Gene Therapies Team in Boston, MA. The experienced leader will be a member of the AD Leadership Team and will play a central role in advancing our programs and...
