Process Development Associate [Contract to hire]

ZipRecruiter; Tampa (FL); On-site; USD 50,000 - 90,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Process Development Associate I, um spannende Projekte im Bereich der Zelltherapie zu unterstützen. In dieser Rolle werden Sie an der Entwicklung und Optimierung von Prozessen für klinische Zellverarbeitung arbeiten und Ihre analytischen Fähigkeiten einsetzen, um Ergebnisse zu interpretieren und zu präsentieren. Wenn Sie eine Leidenschaft für die Biotechnologie haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie. Das Unternehmen fördert Vielfalt und Inklusion und bietet ein unterstützendes Arbeitsumfeld.

Qualifications

• 2+ Jahre Erfahrung in der Zellkultur- und Zelltherapie-Biotechnologie.
• Fähigkeit, Vorschriften und Leitfäden zu verstehen.

Responsibilities

• Unterstützung bei der Prozessentwicklung und der Übertragung von Technologien.
• Durchführung von Charakterisierungstests an Zellprodukten.

Skills

Aseptische Zellkulturtechniken

Analytische Fähigkeiten

Kommunikationsfähigkeiten

Microsoft Office Suite

Teamarbeit

Education

Bachelor in Naturwissenschaften oder verwandtem Bereich

Master in Naturwissenschaften oder verwandtem Bereich

Tools

GraphPad

MiniTab

FACS DIVA Software

Job description

Overview

The Process Development Associate I will support process development projects and technology transfer activities related to genetically and non-genetically engineered Tumor Infiltrating Lymphocyte (TIL) clinical trials. A successful candidate will have experience with aseptic cell culture techniques and cell-based immunological assays. Prior knowledge of cGMP practices is beneficial in this role.

Essential Functions and Responsibilities

1. Focus on process development aspects of clinical-scale cell processing, including mammalian cell culture, drug product formulation, and cryopreservation of cell products. Develop new processes or refine existing ones to optimize manufacturing. Perform characterization testing on cell products.
2. Make detailed observations and record them promptly and accurately.
3. Analyze and interpret experimental results, including graphing and statistical analysis.
4. Organize results for team presentation and discussion.
5. Lead or support the writing of protocols and reports.
6. Support data and records management activities.
7. Stay current with new processes and analytical methods.
8. Adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
9. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
10. Perform other related duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor's degree with 2+ years or Master's degree with 0+ years in a life science or STEM-related discipline.
• At least 2 years of experience in cell culture/cell therapy biotechnology industry.
• Proficiency in Microsoft Office Suite.
• Ability to understand regulations and guidance documents.
• Strong analytical and critical thinking skills.
• Effective written and oral communication skills.
• Organized, able to multi-task.
• Team-oriented work ethic.

Additional Skills and Experience

• Proficiency in GraphPad, MiniTab.
• Experience with FACS DIVA software.
• Previous cell therapy experience, especially with TIL or CAR-T, is a plus.
• Experience with immunological assays like flow cytometry and ELISA is a plus.

The physical demands of this role include moving between office and lab, standing or sitting for extended periods, lifting containers up to 15 pounds, and wearing appropriate PPE in the lab.

Mental and Work Environment

Requires clear, conceptual thinking, good judgment, troubleshooting, problem-solving, and stress management. Must handle multiple priorities and meet deadlines. The work environment includes office and laboratory settings, with potential exposure to hazardous materials.

Iovance is committed to diversity and inclusion and is an equal-opportunity employer. For accommodations, contact [e-mail].