What are the responsibilities and job description for the Senior Manager or Associate Director, Analytical Development & Quality Control position at Pheast Therapeutics?
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, to
- support clinical development and regulatory submissions.
- Provide oversight of extended characterization studies, supporting assessment of critical
- quality attributes (CQAs) and comparability exercises.
- Provide detailed review and approve protocols, reports, and raw data for analytical method
- qualification / validation, release testing, and reference materials qualification
- Provide technical support during deviations, CAPAs, and investigations, ensuring timely
- resolution and continuous improvement in collaboration with Quality
- Author and review of relevant sections of INDs, BLAs, and other filings.
- Build and maintain strong relationships with external CDMOs and testing labs to ensure
- alignment and efficiency.
- Support CDMO vendor evaluation and selection activities, including managing requests for
- proposals.
- Stay current with evolving regulatory expectations and industry best practices to maintain
- compliance and innovation.
- Act as analytical subject matter expert (SME) in cross-functional teams with Regulatory,
- CMC, Quality, and Supply Chain
Qualifications :
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.