Senior Scientist, Sterile Oligonucleotide Drug Product Development

Stoke Therapeutics•Bedford, MA

2d•$160,000 - $173,000•Onsite

About The Position

We are seeking a Senior Scientist, Sterile oligonucleotide drug product development, to join our growing CMC team. The role will be responsible for assisting in the development of oligonucleotide drug products and processes by ensuring the timely and efficient delivery of investigational medicinal products.

Requirements

PhD degree in Bio/Chemical Engineering, Pharmaceutical Sciences, Bio/Chemistry, or related scientific field with 4+ years of industry experience or MSc with 6+ years of industry experience or BSc with +10 years of industry experience.
One or more years of experience in oligonucleotide or mRNA sterile drug product development.

Nice To Haves

Good understanding of biopharma/oligonucleotide drug product and process development.
In-depth knowledge and hands on experience with oligonucleotide delivery including but not limited to intrathecal, ocular, intravenous delivery routes.
Experience with ASO-peptide, ASO-antibody, or ASO-small molecule conjugate formulation and process development, including conjugation strategies, purification, and stability characterization of these complex modalities.
Familiarity with bioconjugation chemistry and analytical methods used to characterize ASO-conjugate constructs (e.g., conjugate-specific HPLC, LC-MS, peptide mapping).
Understanding of the unique formulation and stability challenges associated with ASO-conjugated drug products (e.g., aggregation, conjugate stability, immunogenicity considerations for ASO-antibody constructs).
Experience with high-throughput screening and/or analytical characterization techniques of oligonucleotide drug products (UV-Vis, CD, SLS/DLS, particle characterization, FTIR, IR, DSC, chromatography, etc.).
Ability to deal with complexity, strong problem-solving and self-directional abilities.
Demonstrated ability to independently lead, design, conduct, and analyze experiments.

Responsibilities

Conduct hands-on work to develop oligonucleotide prototype formulations in-house, perform testing, and apply Design of Experiments (DOE) where applicable to optimize and scale up processes from R&D to full-scale manufacturing at contract facilities.
In-depth theoretical knowledge and hands-on experience with physicochemical and biophysical characterization methods and techniques including DSC, UV/VIS, CD, HPLC, LC-MS, particle counting and sizing, osmometer, viscometer and others.
Demonstrated scientific track record in translatable in oligonucleotide drug product process development by industry experience and/or external scientific publications and patents.
Strong background in applying a sound scientific approach to experiment design and data analysis/interpretation.
Experience in authoring reports, methods and regulatory filings, and demonstrated working knowledge of applicable and emerging FDA, EMA ICH, and other regulatory requirements.
Participate in the selection of manufacturing equipment, overseeing the process from prototype development to full-scale production of oligonucleotide drug products, both in-house and at contract manufacturing organizations when necessary.
Provide support to manufacturing operations, as required.
Implement problem-solving techniques to identify, assess, and mitigate potential manufacturing issues.
Familiarity with risk assessment tools like FMEA, FMECA, Fish-bone diagrams and so on to minimize drug product manufacturing risks.
Review technical documents such as engineering studies, Master Batch Record (MBR), Executed Batch Records (EBR), Filter Validation Protocols and other related process validation protocols and manufacturing plans.
Familiarity with tools but not limited to like JMP, Master control, Veeva, Prism etc.
Travel to CMO as required (5-10%)