Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Cook - No Late Nights
Recruited by Slows Bar BQ 10 months ago Address Detroit, MI, United States
Customer Support Specialist (Late Hours)
Recruited by Everlaw 11 months ago Address , Oakland, 94612, Ca $33.65 - $40.86 an hour
Leo Lecturer I - Resident Stage Manager
Recruited by University of Michigan 11 months ago Address , Ann Arbor, 48109, Mi
Yard Hand Jobs
Recruited by 123.NET 1 year ago Address , Byron Center, 49315, Mi
Research Scientist - Formulation & Process Development
Recruited by Gilead Sciences 1 year ago Address Foster City, CA, United States
Sr. Research Scientist I, Formulation Process Development
Recruited by Gilead Sciences 1 year ago Address , Oceanside, Ca $157,165 - $203,390 a year

Director, Late-Stage Upstream Process Development

Company

Gilead Sciences
Address , Oceanside, Ca
Employment type FULL_TIME
Salary
Expires 2023-07-19
Posted at 11 months ago
Job Description
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

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.
Role and Responsibilities:
The Director, Late-Stage Upstream Process Development will have accountability for strategies and work including late-stage upstream process development, scale-up, upstream process robustness and characterization, and upstream process validation and control. The successful candidate will author relevant sections of BLAs, late-stage regulatory filings, and supporting reports. In this role, you will also manage a team of scientists and research associates who conduct the above activities. You will have the opportunity to lead cross-functional teams and represent upstream development on cross-functional teams.
Essential Duties and Job Functions:
  • Drives process improvements for increased speed and efficiency to generate highly productive, upstream manufacturing processes that deliver high quality product.
  • Manages upstream functional resources that support multiple cross-functional teams.
  • Authors relevant sections of BLAs, late-stage regulatory filings, and supporting reports and information requests.
  • Focuses on strategic planning and execution while managing within the budget.
  • Develops and motivates team and develops careers of direct and indirect reports.
  • Supports upstream process-related technology development.
  • Defines strategies for late-stage development.
  • Drives business process improvements related to late-stage process development.
  • Leads a team of scientists that is responsible for upstream process development, scale-up, upstream process robustness and characterization, and upstream process validation and control.
  • Some travel may be required to support internal and external technology transfers and provide manufacturing oversight of CMOs.
  • Ensures compliance to safety, business policies, laws, and regulations applicable to the operations.
  • Supports investigations and identifies root causes for critical deviations.
  • Reviews GMP and non-GMP technical documentation (batch records, SOPs, and process validation/characterization protocols and reports).
Knowledge, Experience and Skills:
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
  • 8+ years of experience in the pharmaceutical industry and PhD in a relevant scientific discipline such as Chemical Engineering, Bioengineering, or Biochemical Engineering or BS or MS with extensive industry experience.
  • Experience with technology development/implementation projects both functionally and cross-functionally is preferred.
  • Excellent interpersonal, communication, and presentation skills are required.
  • Experience with antibody and antibody-like proteins is required; experience with other modalities preferred.
  • Demonstrated excellence in cell culture and upstream process development, process technology transfer, scale-up, and statistical DOE (design of experiments) is required; strong understanding of phase-appropriate development preferred.
  • Experience supporting commercial manufacturing is preferred.
  • Supervisory experience is required.
  • Experience with the preparation of regulatory filings for US or external markets including BLAs is required.
  • Experience with leading the strategy and work of late-stage process development, upstream process characterization, and upstream process validation and control is required.
  • Flexibility and a willingness to expand skill set and responsibilities is a must.
If this is not the right move for you now but you remain interested in a career at Gilead Sciences, please connect with us via our talent community:
https://gilead.avature.net/Gilead
.
About Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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 for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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.