Director, Analytical Development
About The Position
As the Director of Analytical Development reporting to the Senior Director, Analytical Chemistry, you will be responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. You will drive method innovation, ensure alignment with regulatory expectations, and partner cross-functionally to support process development, formulation, CMC, and quality activities. In this role, you will bring deep technical expertise, proven leadership, and the ability to operate effectively in a fast-paced, growth-stage biotech environment. This role is based out of either our San Francisco or Boston offices and will require 10% travel.
Requirements
- PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration
- Minimum of 5 years direct leadership experience on managing internal and external teams
- Expertise of cGMP, ICH, and FDA regulations/guidance
- Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
- Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
- Experience in partnering with cross functional teams providing analytical development leadership across programs and projects
- Demonstrated interpersonal skills, including strong oral and written communication abilities
- A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally.
- Strong initiative and follow-through are essential for this role
- Aspires to the highest of scientific and ethical standards
- Ability to multi-task and shift priorities rapidly to meet tight deadlines
- Keen to improve processes and overcome inefficiencies
Responsibilities
- Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
- Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
- Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
- Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
- Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
- Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
- Represent Analytical Chemistry at internal and external scientific team meetings as needed
- Remain current with state-of-the art approaches and applicable global regulations and industry standards
Benefits
- We offer a competitive compensation and benefits package
- seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
