About Us
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Our primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus, or HCV. A secondary focus for us is the development of Racivir, for the treatment of human immunodeficiency virus, or HIV. Our research and development efforts focus on a class of compounds known as nucleoside analogs, which act to inhibit the natural enzymes required for viral replication.
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Careers at Pharmasset
| Position: |
Director, Pharmaceutical Product Development |
| Functional Area: |
Manufacturing |
| Location: |
Princeton, NJ |
| Date Posted: |
4/10/2009 |
Responsibilities
- Responsible for process justification, and engineering and validation batch campaigns for commercial development of drug product.
- Develop strategies to effectively deal with formulation challenges that may arise.
- Manage over-encapsulation at 3rd party sites.
- Handle the implementation of stability protocols.
- Collaborate with internal team members and external partners to implement strategies to ensure effective achievement of clinical/commercial manufacturing objectives.
- Oversee the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies.
- Work closely with quality groups to ensure strict compliance with GMP guidelines at all times.
- Ensure the effective use of materials, equipment and people in producing quality products.
- May provide 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.
Qualifications
- 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 solve complex manufacturing problems.
- Proven ability to formulate decisions effectively and independently based on available information.
- Prior experience in managing outsourcing and negotiating contracts with vendors.
- Solid understanding of cGMPs & the operational needs of a Commercial Manufacturing environment.
- Candidate should be a highly motivated individual with demonstrated outstanding verbal and written communication skills.
- 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.
- Demonstrated ability to 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.
- Ability to travel both domestically and internationally approximately 30% of the time is required.
To Apply
Pharmasset, Inc. is an Equal Opportunity Employer. |