Associate Scientist II, Analytical Development

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

Job Description

Job#: 3036507

Our Boston based Radiopharmaceutical client is searching for a Senior Scientist, Analytical Development to join a mission‑driven team advancing next‑generation radioligand therapies for cancer patients.

In this role, you’ll lead analytical method development to support GMP readiness, technology transfer, and the progression of innovative therapeutic candidates. You’ll work closely with cross‑functional partners, CDMOs, and manufacturing teams to ensure analytical robustness, regulatory compliance, and seamless scale‑up.

What You’ll Do

• Develop and optimize analytical QC methods (HPLC, LC‑MS, TLC, GC) to support advancement of lead radiopharmaceutical compounds.
• Transition early‑phase analytical methods into GMP/GLP‑appropriate QC workflows.
• Design and execute phase‑appropriate analytical strategies, including method qualification, verification, and validation for regulatory submissions.
• Serve as a primary point of contact for analytical method tech transfer to CDMO and internal manufacturing sites (approx. 10% travel).
• Author, review, and approve analytical documentation, including protocols, methods, reports, and regulatory sections (IND/IMPD).
• Train QC personnel in analytical techniques, data interpretation, and best practices to ensure consistency and data integrity.
• Support OOS/OOT investigations, root‑cause analysis, and CAPA implementation.
• Maintain compliance with GMP, GLP, and data‑integrity standards while contributing to continuous improvement.

What You Bring

• PhD in chemistry, pharmaceutical sciences, or related field with 5+ years of experience (or MSc with 10+ years / BS with 12+ years).
• Hands‑on experience working with radioactive materials (radiopharmaceuticals, medical isotopes).
• Strong background in analytical method development and separation science.
• Deep working knowledge of cGMP and ICH/FDA guidelines.
• Experience with project management and external partner oversight (CROs/CDMOs).
• Excellent technical and regulatory writing skills.
• Ability to collaborate across functions and influence without direct authority.
• High attention to detail and a data‑integrity‑driven mindset.
• Comfort working in a laboratory environment (up to 8 hours/day; able to lift up to 30 lbs).
• Familiarity with chromatography software, LIMS, and Microsoft Office.

If you’re passionate about shaping the future of radioligand therapy and thrive in a fast‑paced, collaborative scientific environment, this role offers the chance to make a meaningful impact.

About Stratacuity

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.