Senior Manager or Associate Director, Analytical ...

Pheast is seeking a highly experienced and motivated individual to join our team as Senior Manager or Associate Director of Analytical Development and Quality Control. The ideal candidate will have extensive experience working with biologics and complex molecules, such as antibody-drug conjugates (ADCs) and bispecific antibodies. This individual will lead efforts to oversee analytical activities at contract development and manufacturing organizations (CDMOs). This position will report to the Director, CMC.Responsibilities (position responsibilities may include, but are not limited to):Lead the development, optimization, and validation of analytical methods for biologics,including complex molecules (e.g., ADCs, bispecifics), ensuring phase-appropriate strategies.Oversee QC activities at CDMOs, ensuring compliance with cGMP and regulatory guidelines.Manage stability programs, including study design, data analysis, and trend evaluation, tosupport clinical development and regulatory submissions.Provide oversight of extended characterization studies, supporting assessment of criticalquality attributes (CQAs) and comparability exercises.Provide detailed review and approve protocols, reports, and raw data for analytical methodqualification/validation, release testing, and reference materials qualificationProvide technical support during deviations, CAPAs, and investigations, ensuring timelyresolution and continuous improvement in collaboration with QualityAuthor and review of relevant sections of INDs, BLAs, and other filings.Build and maintain strong relationships with external CDMOs and testing labs to ensurealignment and efficiency.Support CDMO vendor evaluation and selection activities, including managing requests forproposals.Stay current with evolving regulatory expectations and industry best practices to maintaincompliance and innovation.Act as analytical subject matter expert (SME) in cross-functional teams with Regulatory,CMC, Quality, and Supply ChainQualifications:Advanced degree (PhD, MS, or BS) in Biochemistry, Analytical Chemistry,Pharmaceutical Sciences, or a related field with commensurate industry experience; ForSenior Manager: Minimum of 8 years of relevant industry experience; For AssociateDirector: Minimum of 10 years of relevant industry experienceHighly experienced in analytical method development, validation, and tech transfer forbiopharamaceuticalsHands-on experience with complex molecules, such as ADCs and bispecific antibodies, ishighly desirable.Strong expertise in analytical techniques such as HPLC, mass spectrometry, ELISA, CESDS,and bioassays.Proven experience managing external partnerships with CDMOs and testing labs.Deep understanding of regulatory requirements and ICH guidelines related to analyticaldevelopment and quality control for biologics.Excellent organizational, communication, and problem-solving skills.Demonstrated ability to work collaboratively in a fast-paced, dynamic environment.Pheast is proud to be an equal opportunity employer and we value diversity. Pheast does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Created: 2025-03-03