QC Specialist I - Cell Therapy

Gilead Sciences, Inc.; Santa Monica (CA); On-site; USD 80,000 - 104,000; Full time

Job summary

Kite, a Gilead company, is seeking a Quality Assurance Associate to enhance our commitment in developing cancer therapies. The role involves testing, maintaining lab equipment, and ensuring compliance with GMP standards. We are looking for candidates with a strong scientific background and hands-on experience in quality control within the biotech sector.

Benefits

Eligible for annual bonus

Paid time off

Company-sponsored medical, dental, vision, and life insurance

Qualifications

• 2+ years relevant work experience required for BS holders.
• Strong understanding of GMP and analytical methods.
• Experience in the biotech and/or pharmaceutical industry preferred.

Responsibilities

• Perform testing of raw materials and finished products.
• Maintain and operate instruments for analytical methods.
• Monitor compliance and report OOS results.

Skills

Communication

GMP Knowledge

Analytical Techniques

Quality Control Process

Education

BS Degree in a scientifically oriented field

MS Degree in a scientifically oriented field

Job description

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

Responsibilities (include but are not limited to):
Perform testing of raw materials, intermediates, final products, and stability by following analytical methods.
Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
Track and test products according to Stability protocols.
Work with internal and external resources to maintain lab in an optimal state.
Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
Assist in the preparation of dossiers and data packages for interactions between Kite ( GILEAD) and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Develop, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Gather metric information for use in continuous improvement of areas of responsibility.
Perform other duties as required.

Basic Requirements:

• BS Degree in a scientifically oriented field and 2+ years related work experience
• MS Degree in a scientifically oriented field and 0+ years related work experience

Preferred Requirements:

2+ years of industry experience working in a the biotech and/or pharmaceutical industry Quality related role
Strong knowledge of GMP, SOPs and quality control processes.
Identifying, writing, evaluating, and closing OOS’s and investigations.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel
Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.

The salary range for this position is: $80,325.00 - $103,950.00. Kite 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*.

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

Responsibilities (include but are not limited to):
Perform testing of raw materials, intermediates, final products, and stability by following analytical methods.
Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
Track and test products according to Stability protocols.
Work with internal and external resources to maintain lab in an optimal state.
Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
Assist in the preparation of dossiers and data packages for interactions between Kite ( GILEAD) and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Develop, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Gather metric information for use in continuous improvement of areas of responsibility.
Perform other duties as required.

Basic Requirements:

• BS Degree in a scientifically oriented field and 2+ years related work experience
• MS Degree in a scientifically oriented field and 0+ years related work experience

Preferred Requirements:

2+ years of industry experience working in a the biotech and/or pharmaceutical industry Quality related role
Strong knowledge of GMP, SOPs and quality control processes.
Identifying, writing, evaluating, and closing OOS’s and investigations.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel
Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.

The salary range for this position is: $80,325.00 - $103,950.00. Kite 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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Kite Pharma 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045895

Full Time/Part Time Full-Time

Job Level Associate

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