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Manager, Outsourced Manufacturing - API

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 12, 2022

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Job Details

Manager, Outsourced Manufacturing - API
United States - California - Foster CityCanada - Alberta - Edmonton

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

For Current Gilead Employees and Contractors:

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

Job Description


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 our workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 Sciences, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The Manager of Outsourced manufacturing will play a critical role within the Chemical Development and Manufacturing (CDM) organization to drive multiple projects at both clinical development and commercial manufacturing stages. The Manager will ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in good quality and in full compliance. The Manager will have the opportunities to work with and learn from colleagues across Gilead (Process Chemistry, Regulatory, Formulations, Analytical, Quality and Supply Chain), as well as multiple CRO and CMO organizations. Strong technical skills chemistry/engineering, GMP regulation and drug development) and business skills such as contract negotiation, project management and financial analysis will be called upon at this position.

With the commitment and drive you bring to the CDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters and everyone has a chance to enhance their skills through on-going 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 CDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Specific Responsibilities and Skills:

Technical Responsibilities
  • Manages technical transfer activities to new supplier sites
  • Contributes to the development of complex new concepts, techniques and standards in terms of synthetic routes, process scale-ups, and commercial launches
  • Executes methods, techniques, and evaluation criteria to plan and monitor production of commercial and/or clinical materials
  • Ensures all related manufacturing is consistent with appropriate regulations of GMP, ICH, ISO, or environmental controls
  • Maintains documentation to reflect the effectiveness and efficiency of production and department activities
  • Business Responsibilities
  • Closely monitors and manages supply and demand of commercial and/or clinical materials using advanced planning tools
  • Identifies and purchases custom raw materials, reagents, and other services necessary for the supplies of drug substances
  • Negotiates manufacturing schedules and prices with external suppliers
  • Manages logistics activities for outsourced materials such as warehousing, transportation, customs clearance, and invoicing
  • Frequently interacts with other functional peer group managers within Gilead and CROs/CMOs to support the development or manufacturing activities above


Skills
  • Understanding and application of pharmaceutical process development
  • Ability to effectively manage multiple priorities
  • Working knowledge of GMPs and associated regulations
  • Sound organizational and time management skills
  • Strong negotiation and problem-solving skills
  • Exceptional verbal and written communication skills
  • Ability to interact effectively with senior management


Knowledge and Experience
  • BA/BS degree in Chemistry or Engineering fields plus 7+ years of progressively responsible experience in a related field, including process development, manufacturing, or outsourcing in the pharmaceutical industry.
  • MA/MBA degree or 2 years of relevant experience.
  • Ph.D. degree or 4 years of relevant experience.


If this is not the right move for you now but 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 careers@gilead.com 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 '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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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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