Senior Manager, CMC Analytical Sciences

Stellenbeschreibung:

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

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