Senior Scientist, Formulation Development

Position Summary

The Senior Scientist, Formulation Development will support the ongoing development of macromolecular product candidates using Revance’s proprietary technology.   This individual will play a key role in second generation formulation development for Revance’s lead compound DaxibotulinumtoxinA and in supporting Biosimilar formulation development programs. The individual will design and/or conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects. The individual will provide expertise in drug product design, characterization and delivery using a variety of physicochemical and biological methodologies. This role will interface with various departments to ensure optimal design and comprehensive understanding of new product candidates with special emphasis on functional assays.

Essential Duties/Responsibilities

• Designing and conducting experiments for macromolecular product characterization and functional assessment.
• Designing and/or conducting pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects
• Strong aptitude for applying existing expertise and learning new analytical methodologies across a variety of physicochemical and biological platforms relevant to macromolecules.
• Solving complex problems and serving as a subject matter expert in formulation, process and product development, optimization and scale-up of formulations.
• Maintaining accurate, detailed records of work performed following good documentation practices.
• Writing and reviewing protocols, batch records, batch summary reports, technical transfer documents and product development reports and other key reports/documents as per ICH guidelines and regulatory requirements.
• Train and supervise junior team members.
• Working cross functionally, excellent oral and written communication skills.
• Contributing to regulatory filings and reviews where appropriate.
• Leading specific projects with management input and develop product development plans for projects.

Education

This position requires a PhD in Pharmaceutics or Pharmaceutical Sciences or related scientific field preferably in Formulation Development/Drug Delivery and a minimum of 5 years of relevant experience or Master's degree in Pharmaceutical Sciences with emphasis in Pharmaceutical Formulation and Technology and a minimum of 8 years of relevant experience.

Experience

• Expertise in pharmaceutical development and process and product development experience.
• A minimum of 5 years work experience in the biopharmaceutical manufacturing industry or equivalent is required.
• Experience in various modern analytical assays, applicable to protein therapeutics, including but not limited to UV, HPLC/UPLC, SDS Page and Western Blot; Moisture content analysis using Karl Fischer.
• Hands on knowledge of lyophilization is a plus.
• Should have knowledge of Current Good Manufacturing Practices and Standard Operating Procedures as related to laboratory/manufacturing environment.
• Excellent verbal and written communications skills are essential.
• Should have basic understanding of the Food Drug Administration guidelines and regulations.

Knowledge, Skills and Abilities

Minimum Required:

• Excellent oral and written communication skills are a must.
• Good record keeping skills and attention to detail are essential.
• Proficient in Microsoft Office. Advanced Excel skills required.

Preferred:

• Proficiency with JMP, is a plus