Senior Scientist, Analytical Development at Definium Therapeutics

, , United States -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

143783.0

Posted On

14 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Analytical Method Validation, Contract Laboratory Management, Stability Programs, Data Management, Data Analysis, Trending, Troubleshooting, Out of Specification Results, Out of Trend Results, Investigations, CMC Documentation, Regulatory Filings, cGxP, ICH Requirements, USP Requirements

Industry

Biotechnology Research

Description

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. 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 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 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 The starting base pay range for this position is $119,648 - $143,783. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including: 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!

Responsibilities

The Senior Scientist will build relationships with internal teams and external suppliers, managing contract laboratories performing analytical testing to meet program milestones. This role involves overseeing stability programs, troubleshooting deviations, and authoring analytical CMC sections for regulatory filings.