What are the responsibilities and job description for the Sr. Scientist, Analytical Development position at Stratacuity: Proven Scientific Placement?
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.