At Gilead, weāre creating a healthier world for all people. For more than 35 years, weāve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer ā 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 worldās biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Ā
Every member of Gileadās 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 weāre looking for the next wave of passionate and ambitious people ready to make a direct impact.
Ā
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
Ā
Job Responsibilities:
Conducts method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products.
Ā Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques.
Ā Applies knowledge and complies with GMP in daily activities.
Conducts GMP data review to ensure compliance with applicable Standard Operating Procedures (SOPs), test methods, specifications, and protocols.Ā
Ā Performs regulatory filing analytical data verification to ensure data integrity.
Ā Conducts experiments for troubleshooting failures/investigations under supervisionĀ
Ā Authors and reviews analytical test methods
Ā Supports method transfer to qualify CMOs/CTLs for release and stability testing
Ā Assists in training QC analysts.
Ā Escalates issues and risks to the manager and stakeholders, as applicable.
Specific Education & Experience Requirements:
2+ years of experience with BA or BS degree in Chemistry or Biology.
MS in Chemistry or Biology with 0+ industry experience.
Knowledge and Skills:
Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.
Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments.
Strong working knowledge of cGMP and quality control (QC).
Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
Knowledge in Compliance System (e.g. GVault)
Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.
Excellent verbal and written communication skills.
Ā
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.
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,Ā 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 ApplicantAccommodations@gilead.comĀ for assistance.
For more information about equal employment opportunity protections, please view theĀ '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 Ā legal duty to furnish information; or (d) otherwise protected by law.
Ā
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
gilead