Associate Director, Analytical Development

Olema Oncology•San Francisco, CA

6h•$190,000 - $205,000•Onsite

About The Position

As the Associate Director of Analytical Development reporting to the Senior Director of Analytical Chemistry you will be responsible for driving progress of both early and late-stage molecules by delivering phase - appropriate analytical methods, validation and tech transfers. You will partner with cross-functionally supporting process development, formulations, CMC, and quality activities. In addition, you will bring demonstrated team playing and collaboration skills and experience operating effectively in a fast-paced, growth-stage biotech environment. This role is based out of our San Francisco office and will require 10-15% travel.

Requirements

MS or PhD in Chemistry or equivalent scientific discipline
Expertise in analytical development and quality control for both drug substances (emphasis) and drug product
Knowledge of cGMP, ICH, and FDA regulations/guidance
Minimum of 7+ 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
Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects
Experience in partnering with cross functional teams providing analytical development leadership across programs and projects
Effective written, oral communication and interpersonal skills
Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadline
Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with other
Aspires to the highest of scientific and ethical standards
Keen to improve processes and overcome inefficiencies

Responsibilities

Supporting analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
Conducting analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Reviewing and approving analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Working on stability programs, monitoring/trending stability data and establishing retest periods or shelf lives for drug substances or drug products
Providing technical input and resolving analytical and quality control issues, deviations, OOS and OOT investigations
Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
Representing analytical Chemistry at internal and external scientific team meetings as needed
Staying current with state-of-the art approaches and applicable global regulations and industry standards