Assoc Director, Packaging Engineer na Gilead
Gilead · Foster City, Estados Unidos Da América · Onsite
- Senior
- Escritório em Foster City
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Specific Job Responsibilities
Develop and champion internal business processes to support commercial readiness and lifecycle management of primary container closure systems used in drug product manufacturing
Serve as the technical lead and manage technical relationships with suppliers of primary container closure components
Monitor evolving compendial standards and lead initiatives to ensure continued compliance with regulatory requirements
Support extremely complex technical problems related to primary container closure systems that advance Gilead portfolio priorities
Execute studies and author reports related to container closure system compatibility and manufacturing process development
Evaluate new/novel technologies relevant to parenteral drug product manufacturing
Represent process technologies and development in cross-functional project teams
Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions
Serve as a subject matter expert for development and commercial sterile processing operations
Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members
Preferred Qualifications
Expertise running multifunctional teams and managing technical issues at suppliers and contract manufacturing organizations.
Expertise working swith equipment vendors and manufacturers, process validation, and process characterizations studies.
Execution of root cause analysis, deviation management, and investigation.
Knowledge & Skills:
Excellent verbal, written, and interpersonal communication skills are required.
Must be able to write clear, concise, and error-free documents.
Expert knowledge of FDA and cGMP standards and sterile processing.
Required Education & Experience
Expert knowledge of FDA and cGMP standards and sterile processing.
BA and 10+ years of expereince
OR
MS and 8+ years of expereince
OR
PhD and 2+ years of expereince
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [email protected] for assistance.
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
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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 apply via the Internal Career Opportunities portal in Workday.
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