About the Role >>> Associate Director, Analytical Development 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.
Your work will primarily encompass:
- 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
Ideal Candidate Profile >>> A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge- 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
Experience- 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
Attributes- 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
The base pay range for this position is expected to be
$190,000-$205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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