In drug development, you must know more than science.

Careers

To apply for the position below, email your résumé to Lisa Byrne at careers@artisanpharma.net. Emails only, please.

 

 

Senior Director, Manufacturing

Position Description
Senior Director of Manufacturing reports directly to the CEO and is responsible for the development and oversight of outsourced manufacturing of all Artisan Pharma’s Investigational products, with an emphasis on technology transfer, process development, formulation development, and facility and product supply oversight from Phase 2 through commercial.

 

Responsibilities

  • Develop and oversee the outsourced manufacturing of drug products, with an emphasis on all CMC activities including ART-123 and other biologic and small molecule investigational products.

  • Oversee all aspects of product tech transfer and technical operations/manufacturing at one or more contract manufacturing organizations

  • Provide hands-on direction for outsourcing all aspects of the manufacturing of biologics, including vendor selection, contract negotiation, technology transfer, and process troubleshooting

  • Monitor performance on contracts and milestones to ensure successful delivery of products against time, quality and cost considerations

  • Assist Sr VP of Regulatory and Quality Compliance to author CMC sections of regulatory submissions

  • Organize and conduct facility and manufacturing due diligence on in-licensing product candidates

  • Assist Sr. VP of Regulatory Affairs and Quality Compliance to manage all aspects of validation activities required as per cGMP regulations

Requirements

  • Advanced degree in pertinent area (biochemistry, biology, biotechnology, pharmaceutical or life sciences)

  • 6+ years of pharmaceutical industry experience, preferably with biologics. Commercial experience a plus.

  • Proven experience in pharmaceutical product manufacturing and in all phases and aspects of new product development, including preparation of clinical supplies

  • Expert knowledge and understanding of cGMPs and associated CMC regulatory considerations

  • Demonstrated project leadership capability, ability to handle multiple tasks with aggressive timelines.