Senior Scientist, Formulations

Role Summary

Senior Scientist, Formulations provides technical leadership and acts as a subject matter expert responsible for defining drug product formulation and manufacturing processes to support Pharmaceutical Development milestones and clinical programs. The role focuses on solid oral formulation and/or drug product manufacturing with program leadership experience, specializing in small molecule, solid oral dosage forms from early development through commercialization.

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

Qualifications

• 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