Associate / Senior Manufacturing Technician

Clinical Resource Network (CRN); United States; Vor Ort; USD 80.000 - 150.000; Vollzeit

Zusammenfassung

An established industry player is looking for a Senior Director to lead aseptic manufacturing efforts in a dynamic lab environment. This role involves overseeing the production of cutting-edge genetic therapies, ensuring compliance with stringent cGMP standards, and collaborating with a skilled team to optimize processes. The successful candidate will have a strong background in gene therapy production, quality control, and statistical analysis, making a significant impact on clinical trial investigations. If you're ready to take your career to the next level and contribute to innovative therapeutic solutions, this opportunity is perfect for you.

Qualifikationen

• 1-2 Jahre Erfahrung in aseptischer Herstellung in einer cGMP-Umgebung.
• Kenntnisse in der Herstellung von Gentherapien und viralen Vektoren.

Aufgaben

• Aseptische Herstellung genetischer Therapien unter cGMP-Bedingungen.
• Durchführung von technischen Transfers und Engineering-Läufen für genetische Therapien.

Kenntnisse

Aseptische Techniken

Statistische Analyse

Kommunikationsfähigkeiten

Gene Therapy Production

Qualitätskontrolle

Ausbildung

Bachelor in Biowissenschaften

Bachelor in Chemie

Tools

ELPRO

REES

MasterControl

Jobbeschreibung

Senior Director at Clinical Resource Network, a division of Solomon Page

Our CDMO client is expanding its team. They are seeking those interested in a working career within the lab as Associate and Senior Manufacturing Technicians, open to contract and contract to hire opportunities. This requires fulltime onsite at our facility in the greater Philadelphia area. The successful candidate will support clinical trial investigations and will be involved in various aspects of production and quality control.

Key Responsibilities:

• Upstream and downstream aseptic manufacturing of several genetic therapies under cGMP conditions.
• Execution of tech transfers and engineering runs for genetic therapies.
• Aseptic processing via adherent and suspended cells from vial thaw to purification and dispense.
• Support upstream and downstream commercial contract manufacturing and purification of viral vector therapies.
• Conduct aseptic gowning for Grade C and B Areas, Cell Banking, Aseptic Operator Qualification using the BSC for production, Chromatography, and Buffer Preparation.
• Operate and manage computer programs including ELPRO, REES, and MasterControl.
• Perform ELISA assays to test cell manufacturing efficiency.
• Use statistical methods for data analysis and analytical methods for cell therapies and biological products characterization.
• Conduct unit operation development and process optimizations to reduce production time leading to new production platforms.
• Collaborate with manufacturing team members to author and review SOPs, Batch Records, reports, and memos.
• Assist in developing procedures for new products to ensure standardization, improved quality control, and regulatory compliance.
• Resolve process abnormalities, equipment failures, and yield variances in accordance with regulatory standards.
• Review data to determine causes of product deviation and work closely with quality control to resolve errors.
• Perform daily, weekly, and monthly checks on manufacturing processes and equipment to minimize repair and replacement costs.
• Revise documents, execute protocols, and manage chemical and physical inventory.
• Maintain equipment, manage inventory, monitor the environment, and review records as required.
• Manage deviations, corrective actions, document revisions, equipment maintenance, and calibration.
• Participate in safety committee and employee training initiatives.
• Lead manufacturing implementation of controlled label and training programs.
• Coordinate documents, train employees, and review labels and records.

Qualifications:

• Bachelor’s degree in sciences, Biology, or Chemistry.
• At least 1-2 years of experience in aseptic manufacturing, preferably in a cGMP environment.
• Hands-on experience with gene therapy production, viral vector purification, and cell therapy processes.
• Familiarity with quality control assays, including ELISA and other analytical methods.
• Proficiency in aseptic techniques, chromatography, and buffer preparation.
• Competency with relevant computer programs such as ELPRO, REES, and MasterControl.
• Knowledge of tech transfer processes and engineering runs for genetic therapies.
• Strong statistical analysis capabilities for data interpretation and process optimization.
• Ability to conduct unit operation development and implement process improvements.
• Excellent written and verbal communication skills.
• Experience in authoring and reviewing SOPs, Batch Records, reports, and technical documents.
• Proven ability to resolve process abnormalities, equipment failures, and yield variances.
• Experience in deviation management, corrective action planning, and execution.

If you meet the required qualifications and are interested in this role, please apply today.