Definium Therapeutics · 1 month ago
Senior Scientist, Drug Product Formulation
United States
Full-time
Remote
Senior Level
$118K/yr - $144K/yr
5+ years expDefinium Therapeutics is a clinical stage biopharmaceutical company focused on developing innovative treatments for brain health disorders. As a Senior Scientist in Drug Product Formulation, you will lead the formulation development and manufacturing processes to support pharmaceutical development and clinical programs, ensuring timely delivery and compliance with quality standards.
Biotechnology
Responsibilities
Lead and direct drug product formulation development and manufacturing from conception through clinical development and to commercialization
Partner within pharmaceutical development to define drug product critical quality attributes and control strategies
Evaluate and select phase appropriate, including commercial, manufacturing partners for drug product formulation and packaging
Manage drug product relationships with CDMOs to define and drive technical deliverables, ensuring timely delivery of analytical data to support pharmaceutical development and clinical trials
Review and approve formulation and process development protocols and reports for feasibility, formulation optimization, and scale-up
Review and approve master and executed batch records for formulation and packaging
Analyze/interpret development data to support technical decision making, trend analysis, and root cause investigations
Effectively manage change controls, deviations, and CAPAs to quality standards
Organize and lead authoring of regulatory submissions within Pharmaceutical Development, with expertise in drug product development and manufacturing regulatory file sections. Coordinate input across other technical domains and vendors
Form the Pharmaceutical Development strategy needed to meet program milestones on-time and to quality standards
Represent Pharmaceutical Development on cross-functional clinical study and global program teams
Identify, assess, and drive key Pharmaceutical Development technical decisions and risk mitigations
Manage and lead drug product CDMO interactions in order design, track, and deliver on development milestones
Serve as subject matter expert in formulation, and/or drug product manufacture
Partner with Project Management, Clinical Operations, and Contract Organizations to ensure clinical trial material is packaged, labeled, and supplied on-time and right first time
Qualification
Required
Bachelor of Science degree in Chemistry or relevant discipline with a minimum of 5 years of pharmaceutical industry experience
Strong working knowledge of current Good Manufacturing Practices (cGMP)
Strong working knowledge of relevant regulatory requirements, pharmacopeias, and ICH guidance
Subject matter expert in solid oral formulations, dosage forms, and manufacturing processes, including scale-up and risk management
Proven track record for partnering internally and externally to deliver Pharmaceutical Development milestones on-time and right first time
Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
Experience with US and EU regulatory filings, preferably both at the clinical trial and marketing application stages
Benefits
100% paid health benefits including Medical, Dental and Vision for you and your dependents
401(k) program with company match and vesting after the turn of the first month after your start date
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