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Senior Director, FPD

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Feb 4, 2023

View more

Discipline
Administration, Finance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Senior Director, FPD
United States - California - Foster City

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


With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) 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 PDM 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.

MINIMUM QUALIFICATIONS / TRAINING

A Ph.D. in chemistry (or related science or engineering) with a minimum of 15 years of experience in research and development and/or operations management of processes for the manufacture of pharmaceutical.

5. DUTIES AND RESPONSIBILITIES

5.1. Administrative
  • Manages departmental activities.
  • Determines organizational objectives and establishes organizational policies.
  • Develops scientific and operational strategies of the Formulation and Process Development function.
  • Responsible for the recruitment, selection, management, development and evaluation of staff.
  • Responsible for directing the activities of multiple project teams and assignments through subordinate managers. Ensures that quality, safety and environmental standards are maintained. Ensures that product delivery deadlines are met.
  • Collaborates with contacts across areas and levels to accomplish project goals. Serves as a departmental representative both within and outside the organization.

5.2. Technical
  • Responsible for initiating, directing and executing scientific research for the development of candidates or in research and clinical programs.
  • Directs members of cross-functional teams in the initiation and execution of process development activities, considering economic, regulatory and safety factors.
  • Undertakes short- and long-term planning and supervision of projects.
  • Provides supervision and technical support for manufacturing processes in laboratory and manufacturing plant at Gilead and CMOs.
  • Supports and actively participates in CMC and PDM Sub-teams for commercial products and development projects as required.
  • Works on highly complex problems regularly providing solutions that are highly innovative and ingenious.
  • Investigates the feasibility of applying advanced principles and techniques of related scientific specialty to potential inventions, products and problems. Advances the development of economical, state-of-the art techniques to formulate and manufacture drug product.
  • Ensures batch records and necessary reports (i.e. DV, Quality Investigations etc.) are reviewed in a timely manner.
  • Reviews Development reports, Validation Plans and Protocols, and Validation Reports, and directs validation activities for the assigned projects.
  • Ensures that all operations in the laboratory are carried out in an efficient manner and according to cGLP and cGMP.
  • Serves as an organization spokesperson on advanced projects and/or programs. Acts as an advisor to top management and customers on advanced technical research and development studies regarding long term direction.

5.3. Safety and Environment
  • Ensures that the work environment is kept clean, tidy and that all operations are carried out in a safe manner.
  • Follows all procedures as outlined in the Company Environmental, Health and Safety Policies.
  • Coordinates the Environmental, Health and Safety and Quality (EHSQ) meetings and regular QA and safety inspections of the laboratory areas.

5.4. Quality
  • Attends and obtains passing scores in all required GMP training sessions.
  • Ensures that he/she and any assigned staff have been trained on appropriate SOPs and/or hands on training forms before performing a task.
  • Ensures that SOPs are followed as written and required information is recorded properly.

5.5. Other Duties
  • Responsible for the preparation and review of the site and departmental operating and CAPEX budgets.
  • Ensures that the departmental operating costs and capital expenditures are maintained within approved budgets, or as adjusted by management to current forecasts
  • Carries out other duties identified/assigned by management from time to time

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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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