
Scientist/Sr. Scientist, Radiopharma Development and Tech Transfer (Boston or Salt Lake City)
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Scientist/Sr. Scientist, Radiopharma Development and Tech Transfer (Boston or Salt Lake City)
Independently develop and optimize radiopharmaceutical production processes to support advancement of Ratio’s lead compounds.
Lead the transition of early-phase drug product candidate production methods to processes appropriate for GMP technology transfer.
Design and execute phase-appropriate process development strategies, including process qualification/verification/validation suitable for tech transfer and regulatory submissions.
Serve as a main point of contact for manufacturing process technology transfer to internal and external 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 process related documentation (such as Master Batch records, protocols, reports and relevant sections of IND/IMPD sections and other regulatory filings).
Lead manufacturing process training for manufacturing personnel.
Support OOS/OOT and deviation investigations, identify root cause(s) and implement corrective and preventive actions related to manufacturing operations.
PhD in a life sciences field with 4+ years of relevant industry and/or academic experience (8+ years for MSc, 10+ years for BSc).
Prior experience working with radioactive materials is required.
Demonstrated experience in the development of radiopharmaceutical production processes and radiopharmaceutical manufacturing.
Detailed working knowledge of cGMP and regulatory 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 line-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.).
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Originally posted by Ratio Therapeutics, Inc.. View original posting
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