Senior Scientist, Analytical Development
About The Position
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
Requirements
- Bachelor's degree or above in Pharmacy, Chemistry, or related scientific discipline
- Minimum 6 years of relevant experience working in a pharmaceutical development function, preferably analytical sciences
- Minimum 2 years of experience in the management of contract laboratories performing routine and non-routine testing, method development, and validation
- Strong working knowledge of cGxP requirements and relevant ICH and USP requirements
Nice To Haves
- Working knowledge of JMP or other software for data trend analysis preferred
- Experience with analytical techniques to characterize drug substance a plus
- Solid oral drug product and/or drug substance analytical sciences experience preferred
Responsibilities
- Build strong working relationships with Pharmaceutical Development functional leads, Quality Assurance team, and third-party suppliers
- Provide day-to-day management of contract laboratories performing analytical testing to ensure key program milestones are met
- Oversee stability programs including data management, analysis, and trending
- Troubleshoot out of specification and out of trend results and collaborate with contract organizations and internal Pharmaceutical Development and Quality Assurance teams to guide investigations
- Provide technical guidance during analytical method development and validation
- Author analytical CMC sections of regulatory filings to support on-going and future clinical programs
- Appropriately escalate issues and risks to Senior Management and Pharmaceutical Development Leads
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
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What This Job Offers
Job Type
Full-time
Career Level
Senior
