Kite Pharma · 1 day ago
Lab Ops Specialist I
Frederick, MD
Full-time
Onsite
Entry Level
$69K/yr - $90K/yr
2+ years expKite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The Lab Ops Specialist I will perform testing of raw materials and products, maintain laboratory operations, and ensure compliance with GMP systems.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's Degree OR
AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
Preferred
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, such as swing shift hours
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Mark Jurgens
Vice President, Global Head of Evidence Generation & Strategic Collaborations
Craig Vermeyen
Director, Packaging and Labeling
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase