"Alerted.org

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,** **Formulation** **and** **Proess** **Development** **for Pre-pivotal Biologics** will be responsible for leading first-in-human formulation and drug product process development strategies and enable successful pre-pivotal regulatory filings for biologics in multiple therapeutical areas. This role will also work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.

Responsibilities: 

+ Lead a sub-organization with team leads and scientists; develop a team with focuses on technical excellence, teamwork, and cross-functioanl collaborations; grow employees as formulation scientists and drug product leads for pre-pivotal biologics programs

+ Establish and maintainstate-of-the-art labs that can enable a full spectrum of in-house capability of stability evaluation, biophysical characterizion, process development, and clinical in-use evaluation; capable of setting up new labs

+ Enhanceformulation development workflows for platform molecules and complex biologics that can enable fast-to-clinical timelines and achieve phase-appropriate understanding of molecular properties.

+ Drive technical innovation and encouragescientific investigations;influence internally and externally through publication and presentations; lead by example.

+ Ensure high quality of work; oversee data generation, data integrity, and ensure compliance and excellence from internal and contract organizations.

+ 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, Purification, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.

Basic Qualifications:

+ Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry with 8+ years of industry expereince in biologics CMC development with people leader accountabilities.

OR

+ M.S. in Pharmaceutical Science, Chemistry, Biochemistry with 10+ years industrial expereince in biologics CMC development with people leader accountabilities.

•OR

+ B.S. in Pharmaceutical Science, Chemistry, Biochemistry with 12+ yearsof industrial experience in biologics CMC development with people leader accountabilities.

Preferred Qualifications:

+ Extensive experience withformulation development, drug product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats, in a wide concentration range from ultra low to high;extensive experience of IND filings.

+ Experience with GMP manufacturing of biologics drug product.

+ Well versed in FDA, EMA, and ICH guidelines and GLP/GMP requirements relating to drug product development.

+ Publication and external presentationtrack recordsdemonstrating strong technical innovation capabilities and industrial influence.

+ Established people leader with experience leading teams and growing talents.

+ Strategic thinkerwith business acumen.

+ Late-stage/pivotal phase development experience and leadership, and BLA filing experience is highly desired.

+ Experience working with contracted organization is highly preferred.

+ Experience in leading digital transformation and/or lab automation is highly preferred.

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: $226,185.00 - $292,710.00. 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:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

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 apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.