Quality Control (QC) Leadership Rotational Program (GELP)Job Title - Scientist II to Sr. Scientist I, Quality Control
A total of 24-month rotation with 1st rotation for 12 months in the U.S., followed by two or three rotations for 3-6 months each. One of the rotations will be in China. Specific rotation plans can be customized.
Rotation options:- US Quality Control Physiochemistry Testing
- US Quality Control Bioassay Impurity Testing
- US Quality Control Microbiology
- US Quality Control Operations Support
- US Analytical Sciences
- CN Quality Control team
Work Location - Canbury NJJob SummaryThe Quality track develops leaders responsible for ensuring compliance with global regulatory standards and maintaining the highest levels of product quality across development and manufacturing operations. Drive continuous improvement in the lab setting.
Responsibilities- Support Quality Control activities such as: analytical method transfer, qualification/validation, in-process testing, drug substance/drug product release testing, raw materials testing, facility and environmental monitoring, Stability program, reference standard generation/qualification/management, and sample management
- Participate in deviation investigations, CAPAs, and change controls
- Assist in regulatory inspections and audit readiness
- Learn about compliance with GMP, FDA, EMA, and global regulations
- Drive continuous improvement in Quality Control.
- Engage in leadership development and mentorship programs
Qualifications- Ph.D. in Life Sciences or related field (Microbiology, Biochemistry, Pharmaceutical Chemistry, etc.) with 0-2-year work experience.
- Knowledge of GMP and regulatory requirements.
- Strong attention to detail and compliance mindset.
- Ability to work cross-functionally in a regulated environment.
- Demonstrated leadership and interest in biopharma.
- Willingness to travel and participate in global rotations (if applicable).
- May require some weekend or evening work hours and conference call time to meet global team time zones and job expectations.
