New · posted Oct 19
Gilead Sciences · Biotechnology
QC Analytical Specialist II
- Frederick, MD
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
**** NOTE: Overnight Shift ****
Shift schedule: Saturday 11:30 PM through Wednesday 10:00 AM.
What you need
Two ways to qualify
Bachelor’s
+ 3+ years of experience
Bachelor’s Degree 3+ years’ experience in biotechnology or related field and Quality Control experience
- or
High school
+ 7+ years of experience
High School Degree and 7+ years’ experience in biotechnology or related field and Quality Control experience
Basic Qualifications
MS Degree
AA Degree and 5+ years’ experience in biotechnology or related field and Quality Control experience
Preferred Qualificationsnice to have
Thorough 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).
Preferred: Experience in the biotech and/or pharmaceutical industry.
Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule.
The salary range for this position is: $92,820.00 - $120,120.00. 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*.
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.
Skills named in this posting
What you'll do
Responsibilities (include but are not limited to)
Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
Work with internal and external resources to maintain lab in an optimal state.
Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
Maintains laboratory instruments for calibration and routine maintenance
Author or revise SOPs, qualification/validation protocols and reports.
Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for 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.
Pay
$92,820 – $120,120 a year
Employer providedFor additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Where you'll work
Frederick, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Frederick, MDWorking conditions
For Current Kite Pharma Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
Equal opportunity, accessibility and legal noticesGilead Sciences's statements, word for word
For jobs in the United States
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 [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
Kite Pharma 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% above the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in Maryland5 roles publishing pay
Senior & Principal roles in the US56 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $92,820 | — | $120,120 |
| Maryland (middle half) | $106,500 | $110,000 | $112,500 |
| All US (middle half) | $78,500 | $95,500 | $113,125 |
This role: Gilead Sciences's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 306 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Gilead's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods6
- Documentation and SOPs6
- Collaboration and leadership5
- GMP and compliance2
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems2
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
Company hiring pulse
Gilead on Regulatory Jobs
- 36
- Open roles
- 32
- Distinct roles
- 6
- Locations
By discipline
- Quality25 69%
- Regulatory11 31%
By level
- Director16 44%
- Manager9 25%
- Senior & Principal8 22%
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QC Analytical Specialist II at Gilead
Open until filled. $93K–$120K a year, employer provided.