67749
Job description
**Job Title: Analytical Development and Quality Control Manager**
Oversee analytical development, quality assurance, and stability processes at contract manufacturing facilities, while playing a vital role in supporting clinical assets and regulatory submissions. Work closely with cross-disciplinary teams to guarantee compliance, handle investigations, and manage analytical documentation pertaining to drug substances and products. A minimum of 10 years of experience in analytical development or quality control within the pharmaceutical sector is required. A deep familiarity with current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH) guidelines, and regulatory applications such as Investigational New Drug (IND), Biologics License Application (BLA), and New Drug Application (NDA) is essential.
BridgeBio Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
