Cell and Gene Therapy Process Specialist
1 week ago
Overview:
Are you enthusiastic about the latest breakthroughs in cell and gene therapy? As a key member of our Technical Development team, you will play an essential role in advancing therapeutic innovations.
Position Summary:
In this vital role, you will oversee and lead various cell and gene development initiatives, acting as a principal subject matter expert in cell therapies.
Job Title: Process Expert
Job Type: Full time; Consultant (6 mo. contract)
Location: East Hanover NJ
Schedule: Monday to Friday; First Shift (HYBRID SCHEDULE)
Compensation: $39.50/per hour
Responsibilities:
As a member of the Technical Development group, you will manage and lead both current and future projects in Cell and Gene development, contributing to interdisciplinary technical development efforts within the broader CGT organization.
Your responsibilities will include acting as a subject matter expert for cell therapy projects, interpreting and communicating findings, evaluating data, and drafting protocols, reports, and other documentation for regulatory submissions. You will also contribute to risk assessments and participate in peer review and process challenge meetings.
Key Duties:
- Design experiments, develop protocols, execute plans, analyze data, and prepare technical reports and presentations.
- Provide scientific and technical leadership to ensure efficient and robust processes for the manufacture and analysis of intermediates, drug substances, and drug products.
- Present scientific and technical work at internal and external meetings and conferences, and publish findings in peer-reviewed international scientific journals.
- Take on a scientific and technical leadership role in teams, projects, networks, and departmental activities.
- Contribute to the outcomes of risk assessments, process challenge meetings, audits, and inspections.
Qualifications:
- Bachelor's degree with 2-3 years of industry experience OR Master's degree with 0-2 years of industry experience.
- Strong scientific background with a comprehensive understanding of CAR-T manufacturing and development processes.
- Recognized expertise in immunology, cell biology, biomarker identification, and clinical research.
Compensation Details:
$35.00 to $39.50 per hour.
Benefits:
Our associates enjoy a range of benefits including medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan. We offer flexibility in choosing coverage that meets individual needs.
Associates may also be eligible for paid leave, including Paid Sick Leave and other paid leave as required by Federal, State, or local law, along with Holiday pay where applicable.
Equal Opportunity Employer:
PDS Tech Commercial, Inc. is an Equal Opportunity Employer/Veterans/Disabled.
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