Associate Director, Analytical Development & QC (Boston, MA)
Cedent, Boston, Massachusetts, us, 02298
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. Personal Information
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How did you hear about this position? Your Legal Work Authorization in the US? Are you currently employed? Will you be able to join us on our W-2? What is your desired salary / hourly rate? If on a Visa, will you be able to transfer your Work Visa to us? What is your motivation for Change/New Job Opportunity? If Currently working, what is your Notice period? What is your current location? Are you ready to relocate? Can you provide proof of legal right to work in the United States? If Hired when will you be able to start?
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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. Personal Information
First name Last name Email Address City State Zip code Phone number Attachments
Attach your Resume Attach Dropbox Paste Attach a Cover letter Attach Dropbox Other Information
How did you hear about this position? Your Legal Work Authorization in the US? Are you currently employed? Will you be able to join us on our W-2? What is your desired salary / hourly rate? If on a Visa, will you be able to transfer your Work Visa to us? What is your motivation for Change/New Job Opportunity? If Currently working, what is your Notice period? What is your current location? Are you ready to relocate? Can you provide proof of legal right to work in the United States? If Hired when will you be able to start?
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