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MindMed · 1 month ago

Senior Scientist, Formulations

United States

Full-time

Remote

Senior Level

$118K/yr - $144K/yr

5+ years exp

MindMed is a clinical stage biopharmaceutical company focused on developing innovative treatments for brain health disorders. The Senior Scientist, Formulations will lead drug product formulation development and manufacturing processes, ensuring successful transition from clinical development to commercialization.

BiotechnologyHealth CarePharmaceuticalTherapeutics

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

Solid oral formulationsPharmaceutical developmentManufacturing PracticesRegulatory requirementsCross-functional collaborationInfluencing skillsCommunication skills