We are seeking a Sr. Scientific Director, Analytical Development to lead our CMC analytical development efforts, including method development and validation, specification setting, and regulatory submissions.
Requirements
- BS/BA degree in Analytical Chemistry, Biochemistry, Chemistry and/or related science discipline and 15+ years of experience
- Masters in Chemistry, Pharmacy and/or related science discipline and 13+ years experience
- PhD in Chemistry, Pharmacy and/or related science discipline and 10+ years of similar experience
- Ability to lead analytical and project teams and being independent on daily interactions with internal cross-functional teams and external analytical CMO/CROs
- Expert in developing advanced analytical methods for biological products
- Proficient in ICH and health authority guidance for analytical method validation, stability, control strategies, CTD, and submission of analytical data
Benefits
- Retirement savings plan (with company match)
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits (medical, prescription drug, dental, and vision coverage)