Cell Therapy Specialist I

Biopharma Careers; Frederick (MD); On-site; USD 60,000 - 78,000; Full time

Benefits offered by this job

Discretionary annual bonus

Discretionary stock-based LTIs

Paid time off

Benefits package

Medical/dental/vision/life insurance

Job summary

Kite Pharma in Frederick, Maryland seeks a Cell Therapy Specialist I to join our state-of-the-art manufacturing team. You will perform and verify GMP manufacturing activities for commercial and clinical cell therapy products, working with cross-functional groups to ensure quality and compliance.

The role requires an associate degree (or a high school diploma with experience) and readiness to operate automated cell-processing equipment in Grade B/C cleanrooms, with training and safety in mind.

Qualifications

• Minimum an associate degree with 1 year of relevant experience, or a high school diploma with 2 years of relevant experience.
• Experience in GMP-regulated manufacturing or aseptic processing is preferred.
• Prior involvement in investigations, deviations, and change control is a plus.

Responsibilities

• Perform and verify manufacturing activities for commercial and clinical cell therapy products in accordance with batch records and SOPs.
• Troubleshoot processing and equipment issues and report findings promptly to management.
• Operate, monitor, clean, and prepare automated cell processing equipment in Grade B and C cleanrooms.
• Maintain strict adherence to cGMP, safety, gowning, and PPE requirements in classified areas.
• Complete required training to maintain proficiency and compliance.
• Identify opportunities to improve manufacturing efficiency and compliance.
• Support investigations, deviations, and change controls as needed.
• Wear respirators when handling hazardous disinfectants as required.

Skills

GMP manufacturing

Cross-functional teamwork

Equipment troubleshooting

Regulatory compliance

Education

Associate degree (1+ year experience)

High School Diploma/GED (2+ years)

Tools

Automated cell processing equipment

cGMP documentation tools

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

We are seeking a highly motivated Cell Therapy Specialist I to join our Cell Therapy Manufacturing team at a state-of-the-art commercial cell therapy facility in Frederick, Maryland. This role is responsible for performing and verifying tasks associated with the manufacture of commercial and clinical cell therapy products in accordance with batch records and standard operating procedures. The Cell Therapy Specialist I works as part of a cross-functional team to execute GMP manufacturing runs in close collaboration with Materials Management, Quality Control, and Quality Assurance.

Key Responsibilities

• Perform and verify manufacturing activities for commercial and clinical cell therapy products in compliance with approved batch records and SOPs
• Troubleshoot processing and equipment issues and communicate findings to management in a timely manner
• Operate, monitor, clean, and prepare automated cell processing equipment in Grade B and C cleanroom environments
• Maintain strict adherence to cGMP requirements, safety standards, and gowning and PPE requirements for classified manufacturing areas
• Complete all required training assignments to maintain technical proficiency and regulatory compliance
• Identify opportunities to improve manufacturing efficiency and compliance
• Support investigations, deviations, and change control activities as needed
• Wear a respirator when working with hazardous disinfectants, as required

Basic Qualifications

• Associate degree with a minimum of 1 year of relevant experience, or
• High School Diploma or GED with a minimum of 2 years of relevant experience

Preferred Qualifications

• Bachelor’s Degree
• Prior experience working in a GMP-regulated manufacturing environment or aseptic processing environment
• Experience supporting investigations, deviations, and change control processes

Physical and Work Environment Requirements

• Availability to work holidays based on operational requirements.
• Ability to work in a cleanroom manufacturing environment
• Ability to wear required PPE, including respirators, for extended periods
• Ability to perform tasks that may require standing, lifting, and repetitive motions

Salary

The salary range for this position is: $60,095.00 - $77,770.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary.

Benefits

• 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*.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Company Information

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.

Equal Employment Opportunity

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.

Other Policies

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.