Biotech Process Development Jobs in Gaithersburg, MD

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

Key Responsibilities:

Global Process Stewardship

• Own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
• Conduct global change control impact assessments to ensure process consistency across the network
• Support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization

Project Leadership & Strategic Execution

• Lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
• Contribute to Global MSAT project portfolio strategy, prioritization, and execution
• Drive cross-functional alignment and ensure reliable execution of network-level initiatives

Operational Excellence & Process Consistency

• Lead global investigations across sites to identify root causes and implement sustainable solutions
• Develop and implement standard investigation frameworks and playbooks
• Ensure adherence to global governance and change management processes to support process harmonization

Network Integration & Cross-Site Support

• Act as a site-agnostic process expert, supporting alignment of site activities with network strategy
• Partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
• Support process harmonization and implementation of best practices across sites

Core Competencies:

• Technical depth & process expertise in late-stage clinical and commercial T cell and viral vector manufacturing
• Leadership without authority across a matrixed, global organization
• Ability to establish business processes, drive standardization and governance in complex environments

• Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy

• Ability to establish business processes, drive standardization and governance in complex environments

Basic Qualificaitons:

• Bachelor's Degree in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 8 years of relevant experience

OR

• Masters in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 6 years of relevant experience

Preferred Qualifications:

• Expertise in process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
• Expertise in viral vector manufacturing is a plus
• Cell culture, cell therapy or aseptic processing experience
• Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation

• Experience in Project Management and Project Management Methodology
• Strong understanding of GMP environment and change control processes
• Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)

• Proactive and willing to accept temporary responsibilities outside of initial job description
• Experience in engineering in highly regulated manufacturing environments

The salary range for this position is: $153,935.00 - $199,210.00. 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 contactApplicantAccommodations@gilead.com 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

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 a 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.