Lead CMC Analytical sub-team (as ASTL) to identify molecule CQAs, design/justify/execute end-to-end control strategies, support CMC process development, issue CoTs, seek Specfication endorsement, and author relevant regulatory filings (Phase I/II IND/IMPD) for biologic drug substance and drug product.
Lead analytical characterization activities for pre-pivotal (Phase I/II) biologic molecules.
Develop and execute analytical methods (using HPLC, CE, iCIEF, LC-MS, etc.) to be used for molecule characterization and/or release testing. Author associated method development reports, test procedures, qualification protocols and reports.
Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing.
Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.
Provide technical support to internal and external cGMP manufacturing operations.
Presents research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings.
Qualifications
Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Science, or related fields with a minimum of 2+ years of Biologics CMC industrial experience, OR M.S. with a minimum of 6+ years, OR B.S. with a minimum of 8+ years industrial experience in Biologics CMC.
Previous experience as Biologics CMC Analytical Lead is required.
Extensive hands-on experience on Biologics (especially mAbs) CMC Analytical Development/Operations and IND/IMPD Submissions
Strong Understanding of FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
Experience with analytical method development, validation, and control strategies of biologic products
Strong communication skills- written, oral, etc.
Demonstrated ability of building strong collaborations with other CMC functions.
Familiar with lab automation, data science and knowledge management is a plus.
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
