QC Analytical Specialist II
Kite Pharma
Summary
NOTE: Overnight Shift. Shift schedule: Saturday 11:30 PM through Wednesday 10:00 AM.
Job description
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.
- Maintain laboratory instruments for calibration and routine maintenance.
- Author or revise SOPs, qualification/validation protocols and reports.
- Assist 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 CFR Part 11/210/211).
- Experience in the biotech and/or pharmaceutical industry.
Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule.
Requirements
- MS Degree OR Bachelor's Degree with 3+ years' experience in biotechnology or related field and Quality Control experience OR AA Degree with 5+ years' experience in biotechnology or related field and Quality Control experience OR High School Degree with 7+ years' experience in biotechnology or related field and Quality Control experience
- Thorough knowledge of GMP, SOPs and quality control processes
- Experience identifying, writing, evaluating, and closing OOS's and investigations
- Proficient in MS Word, Excel, PowerPoint and other applications
- Strong written and verbal communication skills
- Ability to communicate and work independently with scientific/technical personnel
- Well versed in analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
- Experience in the biotech and/or pharmaceutical industry
Benefits
- Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.