Senior Manager, Analytical Development

Location
Menlo Park, California
Posted
Jan 27, 2022
Ref
1111
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Job Description This position will manage outsourced analytical methods development and testing of drug substance and drug product. The position will also be responsible for authoring technical reports, deviations, change controls, and analytical sections of regulatory filings.

Responsibilities
    Manage the development, qualification, validation, and transfer of analytical methods at contract laboratories. Review analytical data from contract partners, provide feedback and facilitate resolution of technical or quality issues. Manage release testing and stability testing of drug product and drug substance at contract laboratories. Assist in selection and management of contract laboratories. Collaborate with other members of CMC team to ensure timely release of clinical products and resolution of product investigations. Author and review technical reports, deviations, and change control documents. Author and review analytical sections of regulatory submissions.
Preferred Skills, Qualifications, or Technical Proficiencies
    Experience in analytical and regulatory requirements, including strong working knowledge of cGMPs, ICH, USP and other relevant regulatory requirements. Good technical understanding of all aspects of analytical testing for small molecule pharmaceutical products. Experience in providing oversight for product release and stability testing at contract manufacturers and laboratories Experience in facilitating resolution of product investigations in a timely manner. Effective written and verbal communication skills. Experienced in drafting regulatory submissions. Able to manage multiple projects effectively. Enjoy working independently and collaboratively as part of a CMC team.
Preferred Education and Experience
    B.S. in Chemistry or relevant technical field, advanced degree preferred. A minimum of 7 years experience in analytical development of new chemical entities in the pharmaceutical industry including managing methods development, validation, and testing at contract testing laboratories. Must have hands-on experience with analytical development techniques used in pharmaceutical industry including LC, LC-MS, GC, and Dissolution.
Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol. Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases.

We have gratitude and appreciation for the commitments and convictions of our employees who share a sense of responsibility to find better ways to improve patients’ lives.