QC Analytical Specialist II

1110 Kite Pharma, Inc.; Frederick (MD); On-site; USD 93,000 - 120,000; Full time

Job summary

Kite Pharma, Inc. is seeking a quality control professional for overnight shifts to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR.

You will monitor lab operations, review data for in-process testing and product release, and assist with deviations investigations. Ideal candidates hold an MS or Bachelor’s in biotechnology or related field with multiple years of QC experience, and are proficient with GMP, SOPs,

Qualifications

• MS Degree or Bachelor’s Degree with 3+ years in biotech QC
• AA Degree with 5+ years in biotech QC
• High School Degree with 7+ years in biotech QC

Responsibilities

• Test raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR
• Maintain lab in optimal state with internal and external resources
• Review test data, enable product release with CoAs
• Support GMP systems and procedures, SOPs, and deviations investigations
• Gather metrics for continuous improvement and assist investigations

Education

MS Degree

Bachelor’s Degree

AA Degree

High School Diploma

Tools

MS Word

Excel

PowerPoint

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 **** NOTE: Overnight Shift **** Shift schedule: Saturday 11:30 PM through Wednesday 10:00 AM.

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.

Basic Qualifications

• MS Degree OR Bachelor’s Degree 3+ years’ experience in biotechnology or related field and Quality Control experience OR AA Degree and 5+ years’ experience in biotechnology or related field and Quality Control experience OR High School Degree and 7+ years’ experience in biotechnology or related field and Quality Control experience

Preferred 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.

Shift Schedule & Working Hours

Potential shifts are Sunday - Wednesday or Wednesday - Saturday. Business need may require alternate work schedule.

Salary & Compensation

The salary range for this position is: $92,820.00 - $120,120.