Director, Manufacturability Assessment, PDM Biologics

Director, Manufacturability Assessment, PDM Biologics

United States - California - Foster City Process / Product Development & Operations Regular

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Director, Manufacturability Assessment (Pre-Pivotal) will be responsible for interfacing with the Research organization, collaborating with Protein Therapeutics in molecule assessment and leading PDM manufacturability assessment including end to end PDM functions. She / He is accountable to provide input and to support candidate selection for Gilead’s biologics entities during pre-pivotal phases of development.

Responsibilities :

Responsible to work with Research and PDM functions to provide PDM support and input to Research molecule assessment.

Accountable to work with Research for candidate nomination and coordinate PDM resource, activities and timeline.

Work with Research and Pre-Pivotal leadership team to align and prioritize biologics assets and their development plans.

Lead PDM cross functional team to assess manufacturability of Gilead’s biologics assets.

Communicate PDM manufacturability assessment results and recommendations to Research and influence candidate selection.

Participate in due diligence efforts to assess external biologics assets.

Responsible to work with project PDM lead and transition development project once it reaches PDM team formation.

Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and PDM functions by providing technical and strategic input.

Qualifications :

Ph.D. with 10+ years or BA / MS with 15+ years in CMC functions or related fields.

Extensive industrial experience in biologics, ADC and viral vector development with people leader accountabilities.

Strong understanding of end to end CMC functions including cell line, cell culture, purification, formulation and analytical method development.

Extensive experience working with and leading cross functional team. Demonstrated ability of building strong collaborations with research functions.

Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.

Strong business acumen, able to balance resource, budget and program milestones.

Leadership qualities of the successful candidate include the following : collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.

Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

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