Senior Analytical Development Scientist

Ratio Therapeutics, Inc.•Boston, MA

15h•Onsite

About The Position

Ratio is seeking a Senior Scientist, Analytical Development to join our growing team of scientists. In this role, the successful candidate will be responsible for analytical method development to support GMP method development and technology transfer. The ideal candidate has a track-record of successful GMP technology development, enjoys working in a collaborative and fast-paced environment, and will seek to maintain trustworthy relationships with interdisciplinary teams at partner organizations.

Requirements

PhD in chemistry, pharmaceutical sciences, or a related life sciences field with 5+ years of relevant industry and/or academic experience; MSc with 10+ years or BS with 12+ years of relevant experience
Prior experience with radioactive materials such as radiopharmaceuticals and medical isotopes is required.
Demonstrated experience in radiopharmaceutical analytical quality control method development (e.g., HPLC, MS, TLC, etc.) and advanced theoretical understanding of separation science.
Detailed working knowledge of cGMP and ICH/FDA guidelines with a strong interest in advancing knowledge in this area.
Experience with project management (experience managing external CROs or CDMOs is an asset).
Proven aptitude in technical and regulatory writing.
Ability to work effectively in a cross functional team environment and to influence without direct authority.
High attention to detail and a quality and data-integrity oriented mindset.
Open-minded and self-motivating attitude.
Computer skills (Microsoft Office suite, chromatography software/LIMS, etc.).
Experience in pharmaceutical manufacturing process research and development is an asset.
Ready and able to work in a laboratory environment for up to 8 hours a day and able to lift up to 30 lbs.

Nice To Haves

Experience managing external CROs or CDMOs is an asset.
Experience in pharmaceutical manufacturing process research and development is an asset.

Responsibilities

Independently develop and optimize analytical quality control methods (such as HPLC, TLC, LC-MS and GC) to support advancement of Ratio’s lead compounds.
Lead the transition of early-phase analytical method development to methods appropriate for technology transfer.
Lead the transition of early phase methods into GMP/GLP appropriate QC methods.
Design and execute phase-appropriate analytical strategies, including method qualification/verification/validation suitable for tech transfer and regulatory submissions.
Serve as a main point of contact for analytical method technology transfer to CDMO and Ratio Manufacturing sites.
Occasional business travel may be required (approximately 10%, Contiguous US) to facilitate technology transfer and troubleshooting activities at CDMO and internal sites.
Author, review, and approve analytical documentation (such as protocols, methods, reports and relevant sections of IND/IMPD sections and other regulatory filings).
Lead analytical method training for quality control personnel in analytical techniques, data interpretation and best practices to ensure consistent execution and data integrity.
Support OOS/OOT and deviation investigations, identify root causes and implement corrective and preventive actions related to analytical methods and instrumentation.
Ensure compliance with GMP, GLP, and data integrity requirements, contributing to inspection readiness and continuous improvement of processes and workflows.