Careers at Pharmasset

This position is responsible for creating and successfully implementing CMC regulatory strategies and enhancing manufacturing chemistry for all Project Team compounds. The incumbent will be the CMC IND correspondent for all projects and will be accountable for the success of all health authority CMC submissions. Manufacturing CMC responsibilities include guidance to third party contractors while interpreting synthetic chemistry and formulation data to ensure high quality submissions and maximum operational efficiency.

• Responsible and accountable for the CMC regulatory strategy for all project team compounds.
• Assumes the IND CMC correspondent responsibility (or equivalent foreign health authority responsibility).
• Analyzes CMC data fairly and recommend alternate regulatory strategies where appropriate.
• Works as the CMC Regulatory leadership position for synthetic and formulation development strategies to meet quality goals and effectively deal with challenges.
• Provides final CMC Regulatory approval of relevant scientific studies and stability protocols.
• Primary liaison with governing organizations such as USAN, USP, EP, etc
• Analyzes the manufacturing process to increase efficiencies while balancing product quality goals.
• Directly manages contractors synthesizing and formulating company products.
• Collaborates with internal team members and external partners to implement strategies to ensure effective achievement of manufacturing objectives.
• Works closely with quality groups to ensure compliance with applicable global regulations and guidelines.
• Ensures the effective use of materials, equipment and people in producing quality products.
• May provide additional support in various phases of the API life cycle for the company’s drug candidates.
• Perform related duties, special projects and/or other functions as required

• Bachelor degree in a scientific discipline is required; an advanced degree (PharmD, Masters, or PhD in a science related discipline) is strongly preferred.
• Minimum of 8-10 years pharmaceutical industry or biotech experience, with at least 5 years hands-on experience in drug product development area is required.
• Demonstrated ability to comprehend and analyze CMC data and subsequently develop regulatory strategies.
• Prior direct experience in the successful execution of IND and/or NDA stage CMC submissions.
• Candidate should be a highly motivated individual with demonstrated outstanding verbal and written communication skills.
• Demonstrated ability to solve complex strategic and tactical issues.
• Prior experience in managing outsourcing and negotiating contracts with vendors.
• Demonstrated ability to assume responsibility and accountability, work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.
• Solid understanding of global CMC regulatory guidances and regulations (e.g., cGMPs)
• Must have desire to work and excel in a rapidly changing, small company environment where a “hands-on” approach is required.
• Comprehensive knowledge of MS Word, Excel and PowerPoint.
• Ability to travel both domestically and internationally as needed.

Pharmasset, Inc. is an Equal Opportunity Employer.