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Gilead

Associate II, Drug Substance Regulatory Strategy

For Current Gilead Employees and Contractors:

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

Job Description

Overview:

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. 

Job Details:

  • Collaborate with process chemistry and analytical operations teams to implement efficient experimental approaches to facilitate construction, alignment, and maintenance of API control strategies to meet current and upcoming regulatory requirements.
  • Author drug substance sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA and marketing applications NDA, MAA, JNDA, CNDA) in collaboration with various contributors and stakeholders.
  • Prepare response to questions related to manufacturing sections and contribute to content and responses for other control topics.
  • Facilitate the potentially mutagenic impurity assessment process in accordance with ICH M7.
  • Compile API elemental impurity assessment summary.
  • Advise development teams on the selection and justification of regulatory starting materials.
  • Identify key regulatory issues with potential cross-project impact and raise awareness with and appropriately influence affected teams as required.
  • Support the maintenance of API control strategies throughout a program’s life-cycle.
  • Provide training to project teams on good writing practices for regulatory and project documentation. 
  • Develop control strategies and the preparation of technically complex drug substance sections of regulatory submissions in line with ICH and regional regulatory requirements in collaboration with other chemistry manufacturing and control (CMC) functional areas (for example: process chemistry, outsourced manufacturing, analytical operations, CMC regulatory affairs).

  • Contribute to a variety of regulatory submissions which may include clinical trial and marketing authorization applications and supplements and responses to agency questions.

  • Participate in DSRS group meetings and present project status, strategic approaches and updates for complex projects.

  • Attend and participate in cross-functional CMC sub-team meetings for supported clinical projects.

  • May identify and implement improvements to group processes to optimize productivity and regulatory outcomes.

Minimum education:

  • Bachelors degree in chemistry with 2+ years of experience, OR Masters with 0+ 

Knowledge, Experience and Skills:

  • Experience in process chemistry is desirable. 
  • Excellent organization skills and demonstrated ability to manage multiple concurrent activities. 
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Familiarity with the concepts of design of experiment including statistical methods, study design and data analysis is a plus.


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:

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

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