The Associate Director, Analytical Chemistry will oversee all analytical chemistry related activities required to support the development, qualification, validation of all required assays for clinical development candidates. Candidate will be also responsible for the review and approval of related reports and serves as the Subject Matter Expert (SME) for both external assay development/analytical development projects and author appropriate sections for regulatory filings as required.
- Provides leadership for the activities associated with the outsourced development of assays relevant to therapeutic oligonucleotides. This includes, but may not be limited to, the development of in-process testing, in-process control, characterization, and method development/optimization.
- Actively contributes to, and assures, the development of science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
- Drives assay development to support timely IND/CTA, NDA, and all relevant ex-US regulatory filings.
- Builds the scientific knowledge, capabilities, and strategies in therapeutic oligonucleotide characterization that enable fast to clinic/fast to market product development and commercialization.
- Performs other tasks and assignments as needed and specified by management.
Required Skills & Experience:
- A Ph.D. in Biochemistry, Biophysics, Analytical Chemistry, or related discipline.
- Minimum of 7 years of progressive, responsible experience in analytical development roles in a pharmaceutical, biotechnology or related environment.
- Demonstrated expertise and applied experience with the analytical methods used for in-process testing, release testing, and characterization.
- Expertise in phase appropriate analytical method qualification and validation.
- Demonstrated knowledge of CMC analytical and regulatory requirements, including the development of product specifications, and extended analytical characterization.
- Proved knowledge in establishing and managing stability studies.
- Significant experience in laboratory operations, including budgeting, capital expense procurement and IQ/OQ/PQ, and status reporting to Senior Management.
- Knowledge of GLP and GMP requirements as they pertain to analytical development and Quality Control (QC) testing.
- Applied experience with a wide variety of analytical chemistry methodologies including HPLC, mass spectrometry, oligonucleotide sequencing.
- Demonstrate ability to lead/manage analytical development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Stoke operates sites in Bedford, MA, and Cambridge, MA.
Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.
This position will require 10-15% travel.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.