Jobs · OTHR · Massachusetts

Associate Director, Oligonucleotide Development

BioSpace · Waltham, MA · 1 mo ago
On-siteOTHR$159k–$195k/yrFull-time
We need to output only HTML fragment, no html/body tags. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only if posting has real specific content. Let's parse. Company Overview: Could be "About the role"? Actually "Company Overview" is about company, not role. But we can treat as "About the role"? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have sections like About the role (maybe summarizing role summary). Responsibilities: from "Primary Responsibilities Include". Requirements: maybe "Education And Skills Requirements". Qualifications: maybe overlapping with Requirements? But we can separate: Requirements (education/experience), Qualifications (specific expertise), Skills (maybe same). However we must not create thin sections. Let's see content: - Role Summary: description of role. Could be "About the role". - Primary Responsibilities Include: list of responsibilities. - Education And Skills Requirements: includes PhD, 8+ years, then bullet list of expertise (Oligonucleotide Expertise, CMC Lifecycle Mastery, etc). This could be Requirements and Qualifications and Skills combined. But we need to split perhaps into Requirements (education/experience), Qualifications (specific expertise), Skills (maybe same). However we risk thin sections. Better to have one section "Requirements" covering education, experience, expertise, etc. Or we could have "Qualifications" for the bullet list and "Skills" maybe not needed. The instruction: prefer a few substantive sections over many thin ones. So maybe we have sections: About the role, Responsibilities, Requirements (covering education, experience, expertise), Pay (since pay range given), Schedule (onsite 4-5 days/week). Benefits? Not mentioned. So we omit Benefits. Qualifications? Might be redundant with Requirements. We'll not create Qualifications if it's thin. We also need to include Pay range: "MA Pay Range $159,000 - $195,000 USD". So we create a Pay section with that info. Schedule: "Physical presence onsite is expected on 4-5 days/week." So schedule section. We must not repeat job title as heading. Not include Job ID etc. Remove boilerplate: EEO etc. Also remove "Learn more at ..." and social media links? That's company overview but maybe we keep company overview as part of About the role? The instruction: preserve ALL substantive information; do not invent or summarize away detail. So we need to keep company overview details? It's about company, not role. But we could include it in About the role section as context. However "About the role" heading expects role summary; but we can include company overview there as part of description. The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but we should stick to those. So we can have About the role containing company overview and role summary. Responsibilities: list from Primary Responsibilities Include. Requirements: education, experience, expertise list. Pay: pay range. Schedule: onsite expectation. We must use
  • for any list of duties/requirements/benefits. So responsibilities list as ul. Requirements list as ul (maybe each bullet). Pay and Schedule as

    . We must not include filler like "commensurate with experience". Not present. Let's extract details. Company Overview paragraph: "Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook." We should preserve all substantive information; we can keep the learn more link and social media? Might be considered boilerplate? It's not navigation/legal/EEO etc. It's company info. Probably keep. Role Summary: "The Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution both internally and across global CDMOs. This role spans the full development lifecycle - from preclinical process and analytical development through GMP manufacture for IND-enabling studies. The role will ensure the delivery of robust, scalable, and cost-effective manufacturing processes, serve as the primary technical lead for external CDMOs, driving aggressive timelines while delivering well-characterized products optimized for our proprietary bioconjugation platform. As a core member of multiple CMC teams, the Associate Director of Oligonucleotide Development will steer the development of preclinical assets and define CMC strategies within a matrixed environment. The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week." We already used schedule line; but we can keep schedule separate. Primary Responsibilities Include: list bullet points: - Technical Leadership & Strategy - Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply. - Define Analytical Strategy: Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both payloads and conjugated drug substances. - Innovate & Improve: Proactively identify and implement emerging technologies and "continuous improvement" initiatives to enhance product quality and manufacturing efficiency. - Cross-Functional Liaison: Act as the primary CMC representative to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment. Prepare technical source documents, publications, and oral presentations. - Prepare and review relevant CMC and product related sections and documentation for global regulatory submission. - Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports. - External Partner & Project Management - CDMO Governance: Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines. - Technology Transfer: Spearhead the seamless transfer of processes and analytical assays to external partners, ensuring technical success and data integrity. - Issue Resolution: Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions. - Regulatory & Quality Compliance - Regulatory Authoring: Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content. - GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports. - Knowledge Dissemination: Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums. We need to turn these into

    • . Could flatten each bullet as
    • containing the text. Might be long but okay. Education And Skills Requirements: "PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. Oligonucleotide Expertise: Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.CMC Lifecycle Mastery: Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing.External Management: Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.Regulatory Authority: Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).Analytical Depth: Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.Strategic Problem Solving: Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.Collaborative Influence: Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.Project Leadership: Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines." We can split into list items each starting with bold label? We'll just make each sentence as
    • . Could combine first sentence as education/experience. Pay: "MA Pay Range $159,000 - $195,000 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills." We'll put that in

      . Schedule: "Physical presence onsite is expected on 4-5 days/week." Already in role summary but we can put schedule section. We must not duplicate content. If we put schedule in its own section, we should not also repeat it elsewhere? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. It doesn't forbid duplication but better to avoid duplication. We could keep schedule only in Schedule section and remove from role summary. But role summary includes that sentence; we could edit role summary to exclude that sentence, but that would be summarizing away detail (removing). However we could keep it in both places? That would be duplication but preserving detail. The instruction didn't forbid duplication, but we should avoid unnecessary duplication. However removing it would be summarizing away detail (removing). So we need to keep it somewhere. We could keep it in role summary and not have a separate Schedule section, but then we would not have a Schedule section despite having schedule info. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. It doesn't require we must have a Schedule section if we have schedule info; we could embed schedule info in About the role or Responsibilities. But they gave example headings including Schedule. It's optional. We could embed schedule in About the role paragraph. That would preserve detail and not create a thin Schedule section. However they said "Prefer a few substantive sections over many thin ones." So maybe better to have About the role, Responsibilities, Requirements, Pay. That's four sections. Schedule could be merged into About the role or Requirements. But schedule is about work location/expected presence, could be part of About the role. Let's embed schedule in About the role after role summary. Thus sections: About the role (company overview + role summary + schedule), Responsibilities, Requirements, Pay. We must not include Benefits, Qualifications, Skills sections. Now craft HTML. We'll start with

      About the role

      then

      containing company overview + role summary + schedule. Make sure to preserve line breaks? Not needed. We'll need to escape any HTML special characters? Not needed. Now Responsibilities:

      Responsibilities

      then
      • each bullet. We need to capture all bullet points from the responsibilities section. Let's list them clearly: From "Primary Responsibilities Include": - Technical Leadership & Strategy - Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply. - Define Analytical Strategy: Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both

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