Senior Process Development Associate [Contract to Hire]

ZipRecruiter; Tampa (FL); On-site; USD 70,000 - 110,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Senior Process Development Associate, der die Entwicklung und Charakterisierung von Prozessen für klinische Studien unterstützt. Diese spannende Rolle erfordert umfangreiche Erfahrung in aseptischen Zellkulturtechniken und Kenntnisse in der Zelltherapie. Der erfolgreiche Kandidat wird in einem dynamischen Umfeld arbeiten, das sowohl Büro- als auch Laboreinstellungen umfasst. Hier haben Sie die Möglichkeit, an bahnbrechenden Projekten zu arbeiten und einen bedeutenden Beitrag zur Entwicklung neuer Therapien zu leisten. Wenn Sie eine Leidenschaft für biotechnologische Innovationen haben, könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• 5+ Jahre Erfahrung in der Zellkultur oder Zelltherapie in der Biotech-Branche.
• Fähigkeit, Vorschriften und Leitfäden zu verstehen.

Responsibilities

• Entwicklung und Charakterisierung von Prozessen zur Unterstützung klinischer Studien.
• Unterstützung externer Vertragshersteller und Dokumentenüberprüfungen.

Skills

Aseptische Zellkulturtechniken

Analytische Fähigkeiten

Kommunikationsfähigkeiten

Organisationsfähigkeiten

Teamarbeit

Education

Bachelor-Abschluss in Chemieingenieurwesen oder STEM

Master-Abschluss in Chemieingenieurwesen oder STEM

Tools

Microsoft Office Suite

MS Project

GraphPad

MiniTab

Automatisierte Instrumente (z.B. Miltenyi Prodigy)

Job description

Job Description

Salary:

Overview

The Senior Process Development Associate will support process development, technology transfer, and external vendor management activities related to genetically and non-genetically engineered Tumor Infiltrating Lymphocyte (TIL) programs. The successful candidate will have extensive experience with aseptic cell culture techniques, preferably T cells or other immune cells, and previous experience in process development or manufacturing sciences with some knowledge of cGMP/cGLPs. This role is lab-based and will report to Iovance's Tampa, FL facility.

Essential Functions and Responsibilities:

• Process development and characterization supporting TIL clinical trials, including media optimization, mammalian cell culture, genetic modification, drug formulation, and cryopreservation.
• Design, execute, and analyze development and characterization studies; author reports and present findings orally.
• Support external contract manufacturers with document reviews and shipping logistics.
• Manage technology transfer to internal and external manufacturing partners, including training and ongoing technical support.
• Maintain data and records management support.
• Stay current with new processes and analytical methods.
• Adhere to company core values, policies, procedures, and business ethics.
• Comply with safety SOPs, SDS sheets, and OSHA regulations.
• Perform other duties as assigned.

Required Education, Skills, and Knowledge:

• Bachelor’s degree with 5+ years or Master’s degree with 3+ years in chemical engineering or STEM-related discipline.
• At least 2 years of cell culture/cell therapy biotech industry experience.
• Proficiency in Microsoft Office Suite.
• Ability to understand regulations and guidance documents.
• Analytical skills and critical thinking.
• Effective communication skills.
• Organizational skills and ability to multi-task.
• Teamwork skills.

Additional Experience:

• Previous cell therapy experience; TIL or CAR-T experience is a plus.
• Experience with project management software like MS Project or Smartsheets.
• Proficiency in GraphPad, MiniTab.
• Experience with automated instruments such as Miltenyi Prodigy, Lovo, Sepax, Rotea, or similar.
• Experience with cell-based or flow analytical assays is a plus.

Physical Demands and Activities:

• Ability to move between office and lab environments.
• Remain stationary for periods of time.
• Lift containers weighing up to 15 pounds.
• Wear appropriate PPE in lab settings.

Work Environment:

Work involves both office and lab settings, with potential exposure to hazardous or biological waste. Management may modify duties as needed.

Equal Opportunity Statement:

Iovance is committed to diversity and inclusion. We consider all applicants without regard to various protected characteristics. For accommodations, contact [e-mail].

By submitting your application, you consent to the collection and use of your personal data as described in our Candidate Privacy Notice.

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