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Biotechnology, Pharmaceuticals

Senior Scientist, Sterile Oligonucleotide Drug Product Development

Bedford, MAOnsiteFull TimeSenior$160,000–$173,000 /yrPosted 1 month agoVisa sponsorship available

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Required skills

  • BSc
  • oligonucleotide
  • mRNA
  • sterile drug product
  • drug product development
  • CMC
  • investigational medicinal products
  • prototype formulations
  • scale up
  • manufacturing

Nice to have

  • biopharma
  • ASO-peptide
  • ASO-antibody
  • ASO-small molecule conjugate
  • conjugation strategies
  • purification

Role summary

Seeking a Senior Scientist for Sterile Oligonucleotide Drug Product Development to join a CMC team. Responsibilities include hands-on development of oligonucleotide formulations, process optimization using DOE, and scale-up from R&D to manufacturing. Requires expertise in physicochemical and biophysical characterization methods, experimental design, data analysis, and regulatory requirements (FDA, EMA, ICH). The role involves equipment selection, overseeing production at in-house and contract facilities, problem-solving manufacturing issues, and reviewing technical documents. Familiarity with risk assessment tools and specific software (JMP, Master control, Veeva, Prism) is expected. Requires a PhD with 4+ years of industry experience or equivalent (MSc with 6+, BSc with 10+), including at least one year in oligonucleotide or mRNA sterile drug product development.

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

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.

Key Responsibilities:

The ideal candidate will successfully perform each of the following duties:

  • 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%)

    • Required Skills & Experience:

  • 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.

    • Preferred Skills & Experience:

  • 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.

    • Location(s):

    Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This role will be an office based position.

    Travel:

    This position will require approximately 10% travel.

    Compensation & Benefits:

    At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

    The anticipated salary range for this role is $160,000-$173,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

    Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

    Culture & Values:

    At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

    Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

    Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

    https://www.stoketherapeutics.com/careers/

    For more information, visit https://www.stoketherapeutics.com/.

    All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

    Stoke participates in E-Verify.

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