4 дня назад
Principal Scientist, Oligonucleotide (PMO, ASO) Development
159 000 - 200 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Scientist, Oligonucleotide (PMO, ASO) Development (Biotechnology): Leading chemical synthesis, process development, and GMP manufacturing strategies for PMO and modified ASO payload molecules with an accent on scalable processes, impurity control, and physicochemical characterization. Focus on managing CDMO technology transfers, resolving complex manufacturing challenges, and authoring CMC Module 3 content for IND and IMPD filings.
Location: Waltham, MA, United States; onsite presence required 4–5 days per week with no remote option.
Salary: $159,000–$200,000 USD base pay annually.
Company
is a clinical-stage biotechnology company developing oligonucleotide therapeutics for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.
What you will do
- Lead process development and chemical synthesis strategies for PMO and modified ASO payload molecules from preclinical development through GMP manufacturing.
- Define analytical strategies covering impurity control, raw material specifications, and physicochemical characterization of oligonucleotide payloads and conjugated protein drug substances.
- Manage external CDMOs as the primary technical lead, including technology transfers, assay transfers, data integrity, and issue resolution.
- Drive continuous improvement initiatives and implement emerging technologies to improve product quality, scalability, and manufacturing efficiency.
- Review and approve development and cGMP documentation, including tech-transfer protocols, process characterization documents, master batch records, and campaign summary reports.
- Author and review CMC and product-related sections for regulatory submissions, including IND and IMPD Module 3 content.
Requirements
- Bachelor’s degree in biochemistry, chemical engineering, chemistry, pharmaceutical sciences, or a related field.
- 8+ years of relevant pharmaceutical or biotechnology industry experience; an advanced degree is preferred.
- Proven expertise in process chemistry and development of PMO and modified ASO oligonucleotides, including synthesis and purification.
- Experience with analytical development, impurity control strategies, and physicochemical characterization of payloads and conjugated drug substances.
- Direct experience overseeing CDMOs and managing technology transfers.
- Strong problem-solving, communication, and cross-functional leadership skills across internal teams, contractors, and third-party vendors.
Culture & Benefits
- Work in a clinical-stage biotechnology environment focused on life-transforming treatments for neuromuscular diseases.
- Collaborate within a matrixed organization across research, development, regulatory, quality, and external manufacturing partners.
- Contribute to proprietary oligonucleotide delivery and bioconjugation platform development.
- Work is structured as a full-time onsite position in Waltham, Massachusetts.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
5 дней назад
Director, CMC Process Chemistry
206 000 - 254 000$
6 дней назад
Principal Scientist - Oligonucleotide Design and Chemistry
143 200 - 266 000$
1 день назад
Principal Analytical Sciences Scientist (Biotechnology)
108 000 - 176 000$
2 дня назад
Associate Scientist (Oligonucleotide Chemistry & Delivery)
106 000 - 138 000$
2 дня назад
Associate Director, GMP Quality (Biopharmaceutical)
160 000 - 180 000$
1 день назад
Senior Scientist I Analytical Development (Biotech)
112 000 - 135 000$