Principal Scientist, Analytical Development
Dyne Therapeutics
2 months ago
On-site
Waltham, MA
Operations
Role Summary
- Support and oversee analytical method development, method transfer and qualification, and management of CMC activities related to internal/external analytical testing and stability of antibody drug conjugates and intermediates.
- Lead analytical development for several preclinical programs and direct method qualification for GMP production of clinical materials (Phase 1–3).
- Identify, select, and set up a central testing lab (CTL) and coordinate external analytical development with CTLs and CDMOs.
- Partner with Technical Operations and cross-functional teams (Platform Research, Regulatory, Project Management).
Primary Responsibilities
- Oversee analytical aspects for bioconjugate drug substance/drug product, and support PMO/ASO oligonucleotides and small-molecule intermediates (method development, characterization, technology/method transfer, qualification, in-process/release testing, stability).
- Develop analytical strategy for complex biologics/bioconjugates using ICH frameworks.
- Direct external cGMP laboratories for raw material, intermediate, and DS/DP testing.
- Ensure timelines/milestones; manage excursions, deviations, OOS/OOT investigations, and CAPAs within target timeframes.
- Develop/review/approve method transfer/validation protocols and validation approaches.
- Author/review change controls, risk assessments, and product specifications.
- Manage external CMOs and CTLs for method transfer/validation, characterization, and release/stability testing.
- Plan extended characterization to improve product understanding and impurity characterization.
- Support establishment of critical quality attributes (CQAs), specifications, and overall control strategy.
- Partner with QA on cGMP oversight and documents (change controls, deviations, CAPAs, procedures, batch release, stability protocols/programs).
- Support Reference Standard program (establish/maintain reference standards, approve qualification protocols/reports, coordinate release testing).
- Support regulatory CMC documentation (INDs, IMPDs, BLA, RTQs).
- Support internal analytical wet lab work and expansion of the internal AD/CMC lab.
Education & Qualifications
- PhD or equivalent experience in a scientific discipline.
- 8+ years of Analytical Chemistry experience; preferably in a clinical-stage biotechnology company.
- Hands-on experience with SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.
- Bioconjugates/ADCs experience is a plus.
- Self-directed; able to work with limited direction in a fast-paced environment.
- Strong interpersonal, organizational, negotiation, and communication skills.
Onsite Location
- Based in Waltham, MA; not a remote role; onsite 4–5 days/week.
Compensation
- MA pay range: $159,000–$195,000 USD.
- Support and oversee analytical method development, method transfer and qualification, and management of CMC activities related to internal/external analytical testing and stability of antibody drug conjugates and intermediates.
- Lead analytical development for several preclinical programs and direct method qualification for GMP production of clinical materials (Phase 1–3).
- Identify, select, and set up a central testing lab (CTL) and coordinate external analytical development with CTLs and CDMOs.
- Partner with Technical Operations and cross-functional teams (Platform Research, Regulatory, Project Management).
Primary Responsibilities
- Oversee analytical aspects for bioconjugate drug substance/drug product, and support PMO/ASO oligonucleotides and small-molecule intermediates (method development, characterization, technology/method transfer, qualification, in-process/release testing, stability).
- Develop analytical strategy for complex biologics/bioconjugates using ICH frameworks.
- Direct external cGMP laboratories for raw material, intermediate, and DS/DP testing.
- Ensure timelines/milestones; manage excursions, deviations, OOS/OOT investigations, and CAPAs within target timeframes.
- Develop/review/approve method transfer/validation protocols and validation approaches.
- Author/review change controls, risk assessments, and product specifications.
- Manage external CMOs and CTLs for method transfer/validation, characterization, and release/stability testing.
- Plan extended characterization to improve product understanding and impurity characterization.
- Support establishment of critical quality attributes (CQAs), specifications, and overall control strategy.
- Partner with QA on cGMP oversight and documents (change controls, deviations, CAPAs, procedures, batch release, stability protocols/programs).
- Support Reference Standard program (establish/maintain reference standards, approve qualification protocols/reports, coordinate release testing).
- Support regulatory CMC documentation (INDs, IMPDs, BLA, RTQs).
- Support internal analytical wet lab work and expansion of the internal AD/CMC lab.
Education & Qualifications
- PhD or equivalent experience in a scientific discipline.
- 8+ years of Analytical Chemistry experience; preferably in a clinical-stage biotechnology company.
- Hands-on experience with SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.
- Bioconjugates/ADCs experience is a plus.
- Self-directed; able to work with limited direction in a fast-paced environment.
- Strong interpersonal, organizational, negotiation, and communication skills.
Onsite Location
- Based in Waltham, MA; not a remote role; onsite 4–5 days/week.
Compensation
- MA pay range: $159,000–$195,000 USD.