Executive Director, Purification Process Development – Pivotal & Commercial Biologics

Gilead Sciences•Foster City, CA

About The Position

At Gilead, our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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. The Executive Director of Purification Process Development (PPD) will be responsible for leading the development and characterization of purification and conjugation processes for biologics programs from the Pivotal and Commercial stages. This responsibility will also include any post launch Life Cycle Management (LCM) development activities. They will also be a member of the Pivotal & Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Development, Global MSAT, and Materials Sciences).

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.
Proven ability to lead high performing teams.
Exceptional interaction, leadership and command skills are required.
Motivated self-starter with excellent interpersonal and organizational skills.
Excellent verbal communication, oral presentation, and scientific writing 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.
Bachelor's Degree and Fourteen Years’ Experience OR Masters' Degree and Twelve Years’ Experience OR PhD and Twelve Years’ Experience

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.
Develop 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.
Assist with 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.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.