The Principal Scientist will report to the Head of Analytical Sciences and will serve as the analytical lead in cross-functional product development teams to develop analytical methods, identify/qualify impurities, build control strategies, select dissolution media, resolve issues, and advance the portfolio while protecting patients. Bring a high level of understanding of cGMP and of relevant ICH Quality and Safety Guidelines to ensure compliance.
What you'll dive into
Write relevant CMC sections of regulatory dossiers and review responses with a high degree of independence by building complex regulatory rationales to justify specifications, and establish product shelf-lives.
Manage a CMO Network to develop analytical methods, support process chemistry, support formulation development, and provide CTM release and stability testing. Oversee laboratory activities, data reviews, and reporting practices.
Collaborate closely with key partners such as Non-Clinical/Safety Assessment, internal and external Quality Assurance, Business Development and others as needed.
What we expect
PhD in a relevant scientific discipline with 5 years of Analytical Project Lead/CMC experience, MS with 8 years of Analytical Project Lead/CMC experience, or BS with 12 years of Analytical Project Lead/CMC experience
Advanced Skills in analytical method development (e.g. HPLC (chiral and achiral), ultra-high-pressure LC, HSGC, MS, particle size testing, dissolution)
Strong Knowledge of cGMP, ICH Quality and Safety Guidelines, QC Systems, and CTD writing/ reviewing.
What you'll get
To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
Opportunities to learn and contribute creative solutions
Comprehensive health insurance ($0 premium on select medical plans)
Matching 401k retirement plan
Paid time off and holidays
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at firstname.lastname@example.org.