Scientist — Quality Control Biologics Analytical Method Validation and Transfer

Job description

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**

Gilead Sciences, Inc.

is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.



 

**Key Responsibilities: **  

Analytical Method Validation and Transfer **- Commercial** **Analytical Lifecycle Management:**  

+ The Scientist, Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations.

Responsibilities include supporting Commercialanalytical method validations and transfers,compendial review program, andspecification setting strategies.

The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of Commercial biologics drug substances and drug products.

 

 

**Department** ** **  

Global Quality Control – GQC-Biologics  

 

**Job Responsibilities** **  **  

+ Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.



+ In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.

 

+ Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

 

+ Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

 

+ Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

 

+ Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.



+ Demonstrated the ability to motivate and engage individuals.



+ Demonstrated the ability to influence process and outcomes across functions.



+ Willing to support future laboratory work.



+ Willing to support Commercial QC team.



 

**Basic Qualifications:**  

+ PhD in Chemistry, Biochemistry or related field OR 

+ Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR 

+ Bachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience OR 

+ Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience OR 

+ High School Degree and 10+ years of relevant experience  

 

Preferred Qualification:

+ Experience authoring validation protocols and reports for commercial or late-stage products.

+ Experience developing method transfer plans, including authoring gap assessments, master transfer plans, protocols, and reports.

+ Experience interacting with and providing oversight of QC activities at CDMOs and CTLs.

+ Experience leading or participating in the development of product specification setting for commercial or late-stage products.

+ 1+ year of relevant QC experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation and GMP systems/software (e.g. LIMS, QMS, Empower) for biologics drug substances and drug products.



+ Experience in Biopharmaceutical or Pharmaceutical quality control.

Stays ahead of shifting trends in industry.



+ Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.



+ Strong organizational and planning skills.



+ Shows excellent verbal and written communication skills and collaborative interpersonal skills.



The salary range for this position is: $136,340.00 - $176,440.00.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary.

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
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.

Gilead Sciences, Inc.

is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Required Skill Profession

Other General