Principal Scientist, Biologics Pivotal Formulation

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 Principal Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into the clinic. The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and serve as drug product leads on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities: 

• Lead key elements of complex programs, such as portfolio projects, department initiatives, scientific collaborations, new technology assessments, and workflow optimization to help the department reach its goals.

• Design and execute formulation and drug product process development work packages for biologics, to support pivotal formulation development, drug product manufacturing, and clinical in-use evaluations.

• Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions

• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentations.

• Work with functional leaders to develop a functional handbook to pursue business process and technical excellence.

• Represent function and work collaboratively on cross-functional teams to support project team strategy and regulatory filings.

• Drive innovation and continuously grow technical expertise;  influence internally and externally through publication, presentations, and industrial collaboration representation.

• May coach direct reports.

 

Basic Qualifications: 

• PhD / PharmD with 5+ years of relevant experience

• MA / MS degree with 8+ years of relevant experience

• BA / BS degree and 10+ years of relevant experience

• Degree in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields

• Industry experience in biologics CMC development

Preferred Qualifications:

• End-to-end experience of biologics formulation and process development, including both early- and late-stage development experiences. 

• Experience of IND and/or BLA fillings.

• Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.

• Working knowledge of lab automation, data science, and knowledge management. 

• Hands-on in lab execution and has experience of training junior members.

• Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.

• People management experience is strongly desired.

• Experience working with contract development and manufacturing organization is highly preferred.

The salary range for this position is: $195, $253, 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:

* 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  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

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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.

---