Senior Analytical Development Scientist – Radiopharmaceuticals

Apex Systems; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Stratacuity is seeking a Senior Scientist, Analytical Development in Boston to lead analytical method development for GMP readiness and tech transfer to CDMOs and manufacturing sites. You will design phase-appropriate strategies, qualify and validate methods, and ensure regulatory compliance across IND/IMPD submissions.

The role requires a PhD with 5+ years (or MSc with 10+ years) and hands-on radiopharmaceutical experience, with strong data integrity and cross-functional collaboration skills.

Qualifications

• PhD with 5+ years of experience or MSc with 10+ years or BS with 12+ years.
• Hands-on experience with radioactive materials/radiopharmaceuticals.
• Strong background in analytical method development and separation science.
• Deep knowledge of cGMP and ICH/FDA guidelines.

Responsibilities

• Develop and optimize analytical QC methods (HPLC, LC‑MS, TLC, GC) for radiopharmaceuticals.
• Transfer analytical methods into GMP/GLP QC workflows.
• Plan and execute validation/verification for regulatory submissions.
• Serve as primary contact for method tech transfer to CDMO/internal sites (~10% travel).
• Author/review/approve protocols, methods, reports, IND/IMPD sections.
• Train QC personnel in analytical techniques and data interpretation.
• Support OOS/OOT investigations and CAPA.
• Maintain GMP/data integrity standards and drive continuous improvement.

Skills

Analytical method development

HPLC

LC-MS

TLC

GC

Radiopharmaceuticals

cGMP

ICH FDA guidance

Regulatory writing

Project management

CRO/CDMO oversight

Data integrity

Education

PhD in chemistry/pharmaceutical sciences or related

MSc in related field

BS in related field

Tools

LIMS

Chromatography software

Microsoft Office

Job description

Stratacuity is seeking a Senior Scientist, Analytical Development in Boston to lead analytical method development for GMP readiness and tech transfer to CDMOs and manufacturing sites. You will design phase-appropriate strategies, qualify and validate methods, and ensure regulatory compliance across IND/IMPD submissions.

The role requires a PhD with 5+ years (or MSc with 10+ years) and hands-on radiopharmaceutical experience, with strong data integrity and cross-functional collaboration skills.