Executive Director, Biologics Drug Substance Commercialization

About the position

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Executive Director, Biologics Drug Substance Commercialization (BDSC) will report directly to the Vice President of Biologics Science & Technology and will be accountable for delivery of late stage development and commercialization activities associated with drug substance of our pipeline, biologic assets. The incumbent will partner closely with the scientific functions within our research and development division as well as the broader Our Manufacturing Division, to deliver integrated controls strategies that are optimized across the dimensions of cost, quality and speed. Correspondingly, the Biologics Drug Substance Commercialization organization will be responsible for delivering world class outcomes in the following areas: Deliver integrated control strategy and process design elements including process characterization and second generation process development for drug substance processes across multiple expression systems Deliver technology transfer and PPQ elements for drug substance processes in partnership with internal and external manufacturing sites Author and review relevant elements of global regulatory submissions Recruit and develop a world class workforce Ensure core operations and laboratories are compliant with our company's Operating Procedures, and phase appropriate GMP standards, where applicable Ensure a safe workplace for staff across multiple laboratory settings Leadership within and across our company's technical functions Develop and advance cutting edge technologies and business practices Co-chair the Development Council to enable decision making and guidance in order to advance our pipeline assets strategically and technically Create strategic partnerships with external technical collaborators.

Responsibilities

• Deliver integrated control strategy and process design elements including process characterization and second generation process development for drug substance processes across multiple expression systems.
• Deliver technology transfer and PPQ elements for drug substance processes in partnership with internal and external manufacturing sites.
• Author and review relevant elements of global regulatory submissions.
• Recruit and develop a world class workforce.
• Ensure core operations and laboratories are compliant with our company's Operating Procedures, and phase appropriate GMP standards, where applicable.
• Ensure a safe workplace for staff across multiple laboratory settings.
• Provide leadership within and across our company's technical functions.
• Develop and advance cutting edge technologies and business practices.
• Co-chair the Development Council to enable decision making and guidance in order to advance our pipeline assets strategically and technically.
• Create strategic partnerships with external technical collaborators.

Requirements

• Bachelors Degree in life sciences or equivalent with at least 15 years of relevant experience, a Master’s degree (MS) with 12 years of relevant experience, or PhD with 10 years relevant experience.
• Must have expertise and understanding in the commercialization of large molecule drug substance processes.
• Direct experience with management of large, multi-disciplinary scientific organization.
• Excellent written and verbal communication skills.
• Ability to effectively communicate and influence at all levels of the organization.

Nice-to-haves

• Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms.
• Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly.
• Expert knowledge in QbD.
• Excellent organization skills and be able to manage multiple projects simultaneously.
• Excellent interpersonal skills and ability to work.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days