Cell Therapy Analytical Development Scientist

Job Summary:

The Cell Therapy Analytical Development Scientist is a full-time, subject matter expert-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Cell Therapy Analytical Development team. This position will be responsible for developing, implementing and transferring analytical methodologies with an emphasis on new flow cytometry assays to meet internal project and external client requirements for the manufacture, testing, and distribution of cell-based products for patient administration. Aspects of the position will require project management, contributing to project teams, and interfacing with clients. This position requires experience related to all aspects of flow cytometry: generating and processing samples, designing and executing complex flow panels, acquiring and analyzing data and results from a variety of human and murine derived cell populations. This position engage highly with the Translational Sciences and Quality Control groups. This position will report to the Associate Director of Cell Therapy Analytical Development.

Key Responsibilities:

• Act as the subject matter expert for flow cytometry, qPCR, and/or any novel methods of analytical assessment within the Gates Institute product pipeline.
• Serve as technical lead for the transfer of analytical assays from internal and external clients to the manufacturing facility.
• Independently design, execute, and critically analyze experiments and interpret complex data sets.
• Work closely with the research, translational sciences, and Quality Control labs to develop an analytical development plan, release paradigm, and specifications for each product candidate.
• Assist QC with all aspects of assay implementation, including protocol and SOP writing, and training staff.
• Author sections of Development and Production Reports, Batch Production Records, and Chemistry, Manufacturing, and Control sections of INDs.
• Manage tasks to meet project expectations related to timelines, budget, and quality.
• Generate and maintain laboratory notebooks, logs, inventories, and computer databases.
• Assist in monitoring and maintaining processing and testing equipment, facilities, and ordering supplies. This includes routine handling and lifting of laboratory supplies and bench-top equipment, and regular cleaning of laboratory facilities, supplies, and equipment.

Work Location:

Onsite - this role is expected to work onsite with periodic remote work at the manager's discretion, and is located in Aurora, Colorado.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in Biological Sciences, Chemical Engineering, or related field.
• At least 3 years of expertise related to cell-based therapeutics

A combination of advanced degree and related technical/professional experience may be substituted for the bachelor's degree on a year-for-year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Master's Degree or equivalent experience in Cell Biology, Bioengineering, Chemical Engineering, or related field.
• At least 5 years of experience related to cell-based therapeutics.
• At least 4 years of experience working in a cGMP manufacturing setting related to biological and/or cell therapy drugs intended for human use.
• Experience with qRT-PCR, dd/dPCR, ELISA, cell-based assays, cell viability assays, and/or fluorescence microscopy.
• Experience with the isolation, culturing and performing aseptic cell culture manipulations for a variety of human-derived cell populations. Experience culturing and manipulating human-derived iPSC is a plus.
• Experience working in a start-up environment with a track record of being both team-oriented and a self-starter capable of operating independently.
• Prior direct supervision of technical staff.

Knowledge, Skills and Abilities:

• Expertise in flow cytometry
• Expertise in mammalian cell culture
• Demonstrated success in technology transfer and qualification of complex analytical methods.
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Donna.3.Parker@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 6^th, 2024. Those who do not apply by this date may or may not be considered

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $71,909.00 - $91,468.00.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.