Overnight QC Analyst – Biotech GMP & Cell Assays

Kite Pharma, Inc.; Frederick (MD); On-site; USD 93,000 - 120,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Medical/dental/vision/life insurance

Job summary

Kite Pharma, Inc. is seeking a qualified laboratory professional for an overnight shift in Frederick, MD.

You will perform testing of raw materials, intermediates and final products using cell-based bioassays, Flow Cytometry, ELISA and qPCR, ensuring data integrity and GMP compliance. The role requires a degree (MS or BS with relevant experience) or equivalent, and offers a salary range of $92,820 to $120,120 with potential bonuses and stock incentives, plus comprehensive benefits.

Qualifications

• 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.

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.

Skills

Cell-based bioassays

Flow Cytometry

ELISA

qPCR

Lab data trending

SOPs familiarity

Communication skills

Education

MS Degree

Bachelor’s Degree 3+ years’ experience in biotechnology or related field and Quality Control experience

AA Degree and 5+ years’ experience in biotechnology or related field and Quality Control experience

High School Degree and 7+ years’ experience in biotechnology or related field and Quality Control experience

Tools

MS Word

Excel

PowerPoint

Job description

Kite Pharma, Inc. is seeking a qualified laboratory professional for an overnight shift in Frederick, MD.

You will perform testing of raw materials, intermediates and final products using cell-based bioassays, Flow Cytometry, ELISA and qPCR, ensuring data integrity and GMP compliance. The role requires a degree (MS or BS with relevant experience) or equivalent, and offers a salary range of $92,820 to $120,120 with potential bonuses and stock incentives, plus comprehensive benefits.