Senior Scientist, Formulations

As Senior Scientist, Formulations you will be a technical leader and subject matter expert responsible for defining drug product formulation and manufacturing processes to support Pharmaceutical Development milestones and clinical programs.  The ideal candidate will have a core expertise in solid oral formulation and/or drug product manufacturing with pharmaceutical development program leadership experience, with a focused expertise in small molecule, solid oral drug product 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

Requirements: 

• 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

The starting base pay range for this position is $117,894.00 - $143,850.00. 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!