Senior Manager, CMC Analytical Sciences

Direct analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) Provide expert technical leadership in CMC analytical sciences including development, qualification, validation, and transfer of analytical methods Collaborate cross-functionally to ensure analytical strategies meet regulatory expectations Lead and oversee ICH-compliant stability programs including forced degradation studies Compile, review, and analyze analytical data in support of development programs Requirements Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required; advanced degree preferred 9+ years of experience in biopharmaceutical product development, including management of CMC analytical activities Experience in vaccines, cell therapy, or gene therapy strongly preferred Demonstrated experience overseeing CDMOs and/or managing remote external analytical activities Strong technical expertise in biologics and/or vaccine development Hands‑on experience with analytical techniques such as qPCR/RT-PCR, HPLC, ELISA, mass spectrometry, light scattering, and cell‑based potency assays Proven ability to define and justify Critical Quality Attributes (CQAs) Experience supporting GMP manufacturing process characterization strongly preferred In‑depth understanding of US and EU CMC regulatory requirements Comprehensive working knowledge of current Good Manufacturing Practices (cGMPs) Experience authoring CMC sections for INDs, NDAs, BLAs, and ex‑US regulatory submissions Strong attention to detail with excellent organizational and problem‑solving skills Willingness to travel domestically and internationally as needed ATS Optimization Keywords Hard Skills analytical methods qPCR RT-PCR HPLC ELISA mass spectrometry light scattering cell‑based potency assays Critical Quality Attributes GMP manufacturing process characterization Soft Skills technical leadership collaboration attention to detail organizational skills problem‑solving Industry Keywords biopharmaceutical product development vaccines cell therapy gene therapy ICH compliance US CMC regulatory requirements EU CMC regulatory requirements current Good Manufacturing Practices CMC sections for INDs NDA BLA Tools & Technologies CDMOs analytical data analysis stability programs forced degradation studies #J-18808-Ljbffr