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.
 

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
 

Director, Cell Culture Process Development – Pivotal & Commercial Biologics

The Director of Cell Culture Process Development for Pivotal and Commercial Biologics will be responsible for leading the development and characterization of cell culture processes for multiple biologics programs during the Pivotal and Commercial stages. This responsibility will also include post launch Life Cycle Management (LCM) development activities and 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:

• Provide leadership and oversight for multiple pivotal and/or commercial biologic programs.
• Accountable for development and characterization of robust cell culture 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, Regulatory Affairs CMC, and Manufacturing.
• Lead efficient cell culture 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.
• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections.
• Ensure strong relationships with key stakeholder functions including other Biologics Technical Development functions, Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input.
• Demonstrate a knowledge of the cGMP practices and compliance requirements.
• Contribute to defining the strategy toward the next generation Gilead biologics platform. Partner with stakeholders in other functional area to lead projects toward development of the next generation platform.
• 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.
• Hire, mentor and develop team members within the organization to help build and grow a world-class biologics cell culture process development organization.

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 cell culture development with people leader accountabilities.
• Extensive experience in pivotal development, process characterization and commercial support of cell culture operations from seed train to production processes. Experience with perfusion process is a plus.
• Demonstrated experience in process transfer to manufacturing facility and technical leadership in process troubleshooting.
• Strong understanding and extensive hands‐on experience in cell culture process development. In-depth knowledge and deep understanding of mammalian cell culture processes including molecular biology & cell culture engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, single use and stainless bioreactor systems. In-depth knowledge of industry best practices & trends.
• Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post approval changes.
• 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.
• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.
• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence.

People Leader Accountabilities:

• 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)

 

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 [email protected] 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.