Quality Control Analytical, Specialist Ii

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as a QC Specialist I/II in Frederick, MD.

The position reports to the Quality Control Analytical Operations department. In this role, you will work closely with the site’s QC Analytical Operations, Kite’s cross-site QC Technical Services network, and Technical Innovation teams in supporting commercial operations in CAR-T technology.

Note: Should be flexible for shift system. Sun – Wed OR Wed – Sat, 1st or 2nd Shift

Responsibilities:

• Author, revise, and review standard operating procedures, protocols, and technical reports in support of cGMP activities.
• Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
• Initiate and Own quality records in Quality Management Systems (QMS) with a focus on managing Deviations, Lab Investigations, Document life cycle, Corrective and Preventative Actions (CAPA), and Change Controls.
• Implement or lead activities related to the transfer and validation of analytical methods from Clinical to Commercial QC, and Commercial QC to external testing sites in areas of Flow Cytometry, ELISA, Bioassays, PCR/ddPCR, etc.

• Conduct investigations to determination root cause of deviations related to analytical procedures or lab investigations regarding out of specifications (OOS) results.

• Train others and work with cross functional team, as assigned, as a team member or an individual contributor.

• Work with internal and external resources to maintain lab in an optimal state.
• Identify gaps, recommend process improvements, and author/review change controls to implement change to qualified processes and or equipment at Kite pharma and contract labs.
• Maintains laboratory instruments for calibration and routine maintenance
• Provide updates at daily and weekly meetings.

• Perform other duties as desired.

Basic Qualifications:

• Master’s Degree with 2+ years’ experience in a FDA regulated laboratory OR
• High School Degree and 6+ years’ experience in laboratory, preferably in the biotechnology/biopharmaceutical or related field with Quality Control experience
• Bachelor’s Degree with more than 4+ years’ experience in an FDA regulated laboratory, preferably in the biotechnology/biopharmaceutical or related field with Quality Control experience OR
• AA Degree and 5+ years’ experience in laboratory, preferably in the biotechnology/biopharmaceutical or related field with Quality Control experience OR

Preferred Qualifications:

• Well versed in at least 2-3 of analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
• Proficient in Microsoft Office, data analysis software, Quality instruments (such as Veeva), and other related applications.
• Thorough knowledge of GMP, SOPs and quality control processes is preferred
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects

• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Ability to communicate and work independently with scientific/technical personnel.

• Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.
• Thorough written and verbal communication skills.

Does this sound like you? If so, apply today!

The salary range for this position is: $88,145.00 - $114,070.00. Gilead 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.

For jobs in the United States:

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