Associate Director - Analytical Development (Oligonucleotide)
Insmed Incorporated
August 20, 2026
On-site
Bridgewater, NJ
Operations
About The Role
Associate Director, Analytical Development (oligonucleotide-based therapeutics). Provide scientific and strategic leadership for analytical method development, characterization, qualification, validation, and lifecycle management. Lead scientists and collaborate with cross-functional teams (Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners) to execute analytical strategies from early-stage research through commercialization.
What You’ll Do
- Lead analytical development, characterization, qualification, validation, transfer, and lifecycle management of methods
- Define analytical control strategies, specifications, stability programs, and impurity characterization approaches
- Serve as SME in chromatographic and mass spectrometry-based characterization, impurity profiling, degradation pathways, structural characterization, and specification development
- Oversee internal and external (CRO/CDMO) analytical work for quality, compliance, and on-time delivery
- Review/approve protocols, reports, regulatory documentation, and data packages for scientific rigor and data integrity
- Author/review analytical sections of IND/CTA/BLA/NDA; support regulatory agency responses
- Drive innovative analytical technologies and continuous improvement; build and mentor talent; define long-term analytical development strategy
Qualifications
- BS/MS plus 6+ years biopharma experience OR PhD plus 2 years
- 3+ years managing direct reports; experience training/mentoring
- Expertise in chromatography (IP-RP-UPLC, AEX, HILIC) and mass spectrometry-based characterization
- Knowledge of oligonucleotide impurity profiling, stability assessment, and specification setting
Nice to Have
- Chemistry/Biochemistry degree; problem-solving skills
- FDA/EMA/ICH/GMP knowledge; regulatory submission/health authority experience
- CRO/CDMO relationship management; comfortable in diverse environments
Where/Travel
Bridgewater, NJ; full-time, in-person. Occasional travel ~10%.
Pay Range
$155,000–$201,500 annual.
U.S. Offerings (Highlights)
- Medical/dental/vision, mental health support, EAP
- 401(k) match, annual equity awards, ESPP; company-paid life/disability
Application
Current employees: apply via the Jobs Hub in Workday.
Associate Director, Analytical Development (oligonucleotide-based therapeutics). Provide scientific and strategic leadership for analytical method development, characterization, qualification, validation, and lifecycle management. Lead scientists and collaborate with cross-functional teams (Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners) to execute analytical strategies from early-stage research through commercialization.
What You’ll Do
- Lead analytical development, characterization, qualification, validation, transfer, and lifecycle management of methods
- Define analytical control strategies, specifications, stability programs, and impurity characterization approaches
- Serve as SME in chromatographic and mass spectrometry-based characterization, impurity profiling, degradation pathways, structural characterization, and specification development
- Oversee internal and external (CRO/CDMO) analytical work for quality, compliance, and on-time delivery
- Review/approve protocols, reports, regulatory documentation, and data packages for scientific rigor and data integrity
- Author/review analytical sections of IND/CTA/BLA/NDA; support regulatory agency responses
- Drive innovative analytical technologies and continuous improvement; build and mentor talent; define long-term analytical development strategy
Qualifications
- BS/MS plus 6+ years biopharma experience OR PhD plus 2 years
- 3+ years managing direct reports; experience training/mentoring
- Expertise in chromatography (IP-RP-UPLC, AEX, HILIC) and mass spectrometry-based characterization
- Knowledge of oligonucleotide impurity profiling, stability assessment, and specification setting
Nice to Have
- Chemistry/Biochemistry degree; problem-solving skills
- FDA/EMA/ICH/GMP knowledge; regulatory submission/health authority experience
- CRO/CDMO relationship management; comfortable in diverse environments
Where/Travel
Bridgewater, NJ; full-time, in-person. Occasional travel ~10%.
Pay Range
$155,000–$201,500 annual.
U.S. Offerings (Highlights)
- Medical/dental/vision, mental health support, EAP
- 401(k) match, annual equity awards, ESPP; company-paid life/disability
Application
Current employees: apply via the Jobs Hub in Workday.