QC Analytical Specialist II

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

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 (include but are not limited to):

• 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.

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

The salary range for this position is: $92,820.00 - $120,120.00. Kite 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the‘Know Your Rights’ poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.