Director, Purification Development - Pre-Pivotal Biologics

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

The Director of Purification Development for Pre-pivotal Biologics will be responsible for leading molecular assessment, purification development, process transfer and implementation at manufacturing facilities to produce drug substances for toxicology and pre-pivotal clinical studies. He/She will also be responsible for regulatory strategy for Gilead's biologics entities. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.

Responsibilities:

• Establish and maintain state-of-the-art purification labs that enable rapid new biologics entity manufacturability assessment, purification process development and scaleup.

• Lead efficient purification process development and transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Oversee data generation/data integrity to ensure compliance. Lead manufacturing atypical event investigations.

• Drive platform development, new technology/innovation evaluation and implementation and purificaton development operation standardization to enable fast first-in-human clinical trial timeline.

• Hire, mentor and develop scientists, keep abreast of technology and innovation trends as well as best industry practices to establish a highly efficient purification team.

• Serve as, and/or coach employees as, purification lead for PDM (Pharmaceutical Development & Manufacturing) pre-pivotal biologics programs to ensure successful IND/INDa applications.

• Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections.

• Set strategies and develop long-range plans in line with Gilead strategic priorities to deliver on Gilead's long-term ambitions.

• Ensure strong relationships with key stakeholder functions including Analytical Development, Cell Culture Development, Formulation Development, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.

Qualifications:

• Ph.D. in Chemical Engineering, Biochemistry, or related fields with 8+ years experience OR M.S. with 10+ years experience OR B.S. with 12+ years industrial experience in biologics purification development with people leader accountabilities.

• Extensive experience in biologics manufacturability assessment, chromatography, TFF and viral filtration process development and scaleup.

• Demonstrated experience in process transfer to manufacturing facility and technical leadership in process troubleshooting.

• Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in INDs.

• Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.

• Strong business acumen, be 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. 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. Ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Team - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. 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)

The salary range for this position is: $221,170.00 - $286,220.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.