Associate Director - Analytical Development (Oligonucleotide)

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 155,000 - 202,000; Full time

Benefits offered by this job

Medical/dental/vision

Mental health support

Employee Assistance Program (EAP)

401(k) match

Equity awards

ESPP

Life and disability insurance

Job summary

Scorpion Therapeutics in Bridgewater, NJ is seeking an Associate Director, Analytical Development for oligonucleotide-based therapeutics. You will lead method development, qualification, validation, transfer, and lifecycle management, collaborating across PD, Manufacturing, Quality, and Regulatory Affairs to execute analytical strategies from early research through commercialization.

You will serve as SME in chromatography and MS-based characterization, define control strategies, oversee

Qualifications

• BS/MS with 6+ years biopharma experience.
• PhD with 2+ years biopharma experience.
• 3+ years managing direct reports and mentoring teams.

Responsibilities

• Lead analytical development, qualification, validation, transfer and lifecycle management of methods.
• Define analytical control strategies, specifications, and impurity profiling.
• Serve as SME in chromatography and MS-based characterization.
• Oversee internal and CRO/CDMO analytical work for quality and delivery.
• Author/review IND/CTA/BLA/NDA sections and support regulatory responses.
• Drive innovative technologies and mentor talent; shape long-term strategy.

Skills

Leadership

Mentoring

Chromatography

Mass spectrometry

Regulatory knowledge

Education

BS/MS in Life Sciences

PhD in Life Sciences

Tools

Chromatography systems (IP-RP-UPLC, AEX, HILIC)

Mass spectrometry instruments

Job description

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 integrityAuthor/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