About the Roleย >>>ย Associate Director, Analytical Developmentย ย
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 can be based out of our San Francisco, CA or Boston, MA office and will requireย 10-15%ย travel.ย
Your work willย primarilyย encompass:ย
- Supporting analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drugย substancesย and drug productsย
- 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,ย OOSย and OOT investigationsย
- Supporting regulatory filings (IND, IMPD, NDA, MAA) submissions as needed ย
- Representingย analytical Chemistry at internal and external scientific team meetings as neededย
- Staying current with state-of-the art approaches and applicable global regulations and industry standardsย
Idealย Candidate Profileย >>>ย
A love of challenging, important work.ย We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. Allย employeesย within our company play aย unique andย crucial roleย in our success, both inย accomplishingย our mission and buildingย a positiveย company culture. As such, we are looking forย someone withย the right combination ofย knowledge,ย experience, andย attributesย for this role.ย
Knowledge
- MS or PhD in Chemistry orย equivalentย scientific disciplineย
- Expertiseย in analytical development and quality control for both drug substancesย (emphasis)ย and drug productย
- Knowledge of cGMP, ICH, and FDA regulations/guidanceย
Experience
- Minimum ofย 7+ย years of relevant industry experienceย inย small molecule drug substanceย and drug productย analytical development and quality control, including late-stage clinical development and preparation for product registrationย
- Experience working in an environment that strives to ensure internal technicalย expertiseย in-house while driving CDMO capabilities to meet milestones for multiple projectsย
- Experienceย in partnering with cross functional teamsย providing analytical development leadership across programs and projectsย
- Effective written, oral communication and interpersonal skillsย
Attributes
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlineย
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course asย requiredย in a fast-pacedย organizationย
- 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; sharesย expertiseย with otherย
- Aspires to the highest of scientific and ethical standardsย
- Keen to improve processes and overcome inefficienciesย
The base pay range for this position is expected to beย $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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