Definium Therapeutics · 10 hours ago
Senior Scientist, Analytical Development
United States
Full-time
Remote
Mid, Senior Level
$120K/yr - $144K/yr
6+ years expDefinium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Senior Scientist in Analytical Development will manage contract laboratories, oversee stability programs, and provide technical guidance during method development and validation.
Biotechnology
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
Qualification
Required
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
Preferred
Working knowledge of JMP or other software for data trend analysis
Experience with analytical techniques to characterize drug substance
Solid oral drug product and/or drug substance analytical sciences experience
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!
Company
Definium Therapeutics
Definium Therapeutics (formerly MindMed) is a biotech company forging a new era of psychiatry by applying precision to psychedelic medicine.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase