This individual will serve as the interface between research and CMC for Formulation and Fill Finish process development for oligonucleotide candidates. The candidate will also collaborate with CMOs to support formulation and fill finish activities during process development, preclinical, clinical, and potentially commercial manufacturing.
Key Responsibilities Include:
- Design and execute studies for oligonucleotide formulation and fill finish process development, and in collaboration with analytical chemistry characterization, qualification, validation to ensure long-term stability of bulk and vialed drug product.
- Lead formulation and fill finish activity support for technology transfers, formulation, and fill finish process deviations/investigations by designing and executing appropriate studies at CMO.
- Independently design and execute experiments to generate optimal and robust formulation and fill finish process.
- Draft protocols to support internal formulation activities. Review batch records authored by CMOs.
- Interface with Quality Assurance to resolve investigations, deviations, or other quality events.
- with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.
- MS or PhD degree in chemistry, biochemistry, or a relevant field.
- Eight to ten years of experience in formulation, with significant experience with oligonucleotides.
- In depth understanding in the formulation and testing of oligonucleotide drugs.
- Familiar with aseptic processing and fill finish activities.
- Understanding of formulation and fill finish process development, and technology transfer.
- Good understanding of biopharma operations, GMPs, and aseptic processing
- Strong communication skills.
- Excellent analytical thinking and problem-solving skills.
- Ability to work independently in a fast-paced environment.
This position will require approximately 25% travel, both domestic and international.
This position will be primarily located in Bedford, 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.
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.