Job Description

• Manage relationships with contract manufacturers for commercial production, and fill finish
• Ensure successful and timely manufacturing operations for clinical and commercial products
• Manage manufacturing campaigns
• Support product/process and assay technology transfer to contract sites along with the completion of associated qualification and validation activities
• Work with outside groups and consultants to ensure efficient optimization of process parameters, analyze and solve problems, identify risks and develop risk mitigation plans
• Provide technical troubleshooting and analytical support for all manufacturing programs and recommend corrective actions to manufacturing deviations
• Supervise development of validation protocols, analysis of manufacturing results and preparation of manufacturing documentation in support of regulatory submissions
• Serve as the technical resource on development teams to design and implement process improvements, fermentation and asceptic fill/finish operations
• In conjunction with financial and business groups, prepare manufacturing projections, cost estimates and operating budgets for manufacturing activities on all products
Requirements:
Minimum of a BS degree in a life-science discipline with a minimum of 7 to 10 years experience.
Advanced degree in a life-science discipline preferred, along with a minimum of five years experience in large molecule, preferably monoclonal antibodies, drug product manufacturing, including experience with upstream cell culture, protein purification and downstream processing. A thorough understanding of cGMP regulations is required. Requires a clear understanding of the product requirements and deliverables, as well as planning, tracking and managing all tasks and completion dates with development teams. Significant experience compiling CMC data and records for FDA submissions, preferably BLA/NDA submissions.

Excellent communication, writing, presentation, organizational, and interpersonal skills are also required. Must be a hands-on manager willing to take on diverse responsibilities. The position reports to the vice president, development and manufacturing. Adept at using Microsoft project manager. Lyophilization process development and large scale process experience desirable. Ability/willingness to take responsibility, manage projects effectively. Strong leadership skills and demonstrated ability to work independently as well as in a team environment a must.

Years of Experience: 10 years Degree: BS, advanced (preferred)