Director - Formulation & Process Development

Location
Oceanside, CA, United States
Posted
Jun 03, 2021
Ref
2247560
Required Education
Bachelors Degree
Position Type
Full time
Director - Formulation & Process Development
United States - California - Oceanside

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Director - Formulation & Process Development, Oceanside CA

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Gilead has an opportunity for an experienced leader in our Biologics Drug Product Development group at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with scientific expertise in protein formulation and drug product process development, oversight of GMP drug product manufacturing, and global regulatory filings (INDs, IMPDs, BLAs, MAAs).

Essential Duties and Job Functions:
  • Lead and direct a team of scientists/engineers responsible for phase appropriate formulation development and drug product process development for biologics products including monoclonal antibodies, bispecifics, fusion proteins, antibody drug conjugates, etc.
  • Oversee the strategy and execution of development and characterization studies to evaluate formulations, primary container closure systems, in-use subcutaneous and intravenous (IV) delivery systems and conditions, and drug product manufacturing unit operations.
  • Conduct technical transfer, scale-up, and manufacturing oversight for drug product
  • Author and review relevant sections of regulatory filings.
  • Support manufacturing and quality in problem solving production issues and deviation investigations.
  • Develop new technologies to advance state of the art formulations, drug product processes, and delivery systems for biologics products
  • Member of the biologics drug product development senior leadership team contributing to the strategy, growth, and future direction of the department
  • Be an effective communicator of ideas, project goals and results to team members across functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
  • Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
  • Lead, motivate, and develop the people in their group.
  • Routinely make decisions affecting direction of projects to ensure project timelines are met.


Knowledge, Experience and Skills:
  • PhD in scientific or engineering discipline with ≥ 12 years of relevant industry experience in protein formulation and drug product process development.
  • Experienced in both early stage development and late stage/commercial development
  • Experience leading CMC teams
  • Supervisory/management experience is required


To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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:
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