Executive Director, Purification Process Development – Pivotal & Commercial Biologics

About the role

The Executive Director, Purification Process Development leads late-stage purification and conjugation process development and characterization for biologics from pivotal through commercial launch, including post-launch lifecycle management. This role sets strategy and provides technical leadership across cross-functional partners (Technical Development, Quality, Regulatory, Manufacturing, and Supply Chain) to deliver robust processes, effective control strategies, and successful clinical/commercial tech transfers and filings.

Responsibilities

• Provide leadership and direction to the Biologics Purification Process organization, a department of scientists and engineers.
• Accountable for development, characterization, and clinical tech transfer of robust purification processes to support Pivotal clinical and Commercial manufacturing, including Life Cycle Management.
• This includes accountability for developing an integrated control strategy in partnership with organizations across Technical Development, Quality, CMC Regulatory Affairs, and Manufacturing.
• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections.
• Partner with cross-functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Gilead Asset Teams by providing technical and strategic input.
• Demonstrate a knowledge of the cGMP practices and compliance requirements.
• Serve as a member of the Biologics Pivotal/Commercial Technical Development Leadership Team responsible for developing and establishing late-stage Biologics strategy.
• Drive development and implementation of new process technologies to meet business and portfolio needs.
• Remain current on trends and new technology advancements across the Biopharmaceutical industry.
• Aid in due diligence efforts for possible asset purchases and partnership opportunities.
• Establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success through tangible capability improvement.
• Hire, mentor and develop team members within the organization to help build and grow a world-class Biologics Purification Process Development organization.
• Develop and manage department budget.

Requirements

Strong understanding and extensive hands-on experience in purification process development. In-depth knowledge and deep understanding of the development and scale-up of an integrated purification process including harvest, chromatography (resin and membrane), and filtration unit operations. Experience in designing purification processes to deliver to viral clearance regulatory requirements. In-depth knowledge of industry best practices & trends. Experience with conjugation processes is required. Proven experience in control strategy deployment and generation of relevant regulatory sections of IND, BLA and MAA filings. Previous success working effectively in a multidisciplinary, highly matrixed environment. Demonstrated ability to build a team and develop a high performing organization. Excellent decision-making, written and verbal communication skills. Strong self-awareness of the impact communication and working style has on others. Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment. Demonstrated eminence in the scientific community, with desire & ability to shape industry standards. Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, stakeholder management, cross-functional engagement and influence, program management, strategic vision, executive presence.

Qualifications

• Bachelor's Degree and Fourteen Years’ Experience OR Masters' Degree and Twelve Years’ Experience OR PhD and Twelve Years’ Experience

Skills

Excellent verbal communication, oral presentation, and scientific writing skills. Strong self-starter with excellent interpersonal and organizational skills.

Benefits

The salary range for this position is: $281,010.00 - $363,660.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For Additional Benefits Information, Visit here.

Pay

$281,010.00 - $363,660.00

Schedule

N/A