Process Development Jobs in Gaithersburg, MD (NOW HIRING)

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
Kite is seeking a highly motivated individual with cell therapy or biologics manufacturing experience to provide manufacturing support for a new commercial Cell Therapy manufacturing facility in Frederick, MD. The Process Engineer II position is a key technical role within the Manufacturing Science and Technology (MSAT) organization. This role will provide process engineering support for the validation and commercial manufacturing of cell therapy products. Working cross functionally with quality, operations, process development, and facility/engineering functions, the role is expected to provide technical input for deviation investigations, new technology implementation, technology transfers, process validation, and regulatory filings.
Key responsibilities:

• Serve as a subject matter expert to lead product impact assessments for deviations.

• Monitor and analyze manufacturing data to provide support for investigations, continued process verification, and process improvements.

• Participate in process FMEAs to understand process and product risks to support tech transfer and product lifecycle management.

• Participate and report to a cross-functional team to advance production activities and site capabilities.

• Identify continuous improvement opportunities and support implementation in Manufacturing through Operational Excellence

• Ensure a systematic DMAIC based approach is utilized for process/product related investigations to identify root cause and provide impact assessment to support routine manufacturing operations and determine process improvements for manufacturing.

• Support technology transfers for launch and commercialization of cell therapy products.

• Provide technical expertise to support regulatory filings and health authority questions.

• Effectively summarize and communicate manufacturing process performance internally and externally.

• Support the implementation of automation and IT infrastructure projects.

• Design and execute laboratory studies to support process/product understanding and continuous improvement projects

• Author technical documents (protocols & reports for laboratory studies, comparability, and process validation)

Basic Qualifications:

• Master's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 2+ years of industry experience.

• Bachelor's Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 4+ years of industry experience.

Preferred Qualifications:

• Cell therapy experience

• Demonstrated knowledge of biopharmaceutical manufacturing, aseptic processing, cell therapy, and process development

• Practical expertise with cGMP manufacturing and regulatory requirements

• In-depth understanding of scientific and engineering principles

• Experience in statistical analysis using JMP or Minitab

• Knowledge of data management tools and statistical process controls

• Process validation experience including support for regulatory filings and inspections

• Ability to think critically, with demonstrated troubleshooting and problem-solving skills

• Excellent interpersonal, verbal and written communication skills

• Ability to function efficiently and independently in a fast-paced environment

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

The salary range for this position is: $99,705.00 - $129,030.00. 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.