GMP Gene Therapy Manufacturing Associate

Job Detail

DUTIES AND RESPONSIBILITIES:

Perform manufacturing for clinical and commercial materials in GMP setting, including, but not limited to:
1. Assembling raw materials and perform reconciliation in an ERP system.
2. Execute Master Batch Records (MBR) under cGMP, and documents in detail through the use of SOPs and MBRs for the processes and manufacturing steps.
3. Following and assisting in the development of specific standard operating procedures (SOP), MBRs, deviations and summary reports for manufacturing
4. Support initiation and closure of deviations.
5. Support routine cleaning and changeover procedures for cleanroom suites and equipment.
6. Participating in and facilitating technology transfer
Work in a team based, cross-functional environment to complete production tasks.
Adhere to all safety and regulatory requirements while performing job functions.

EDUCATION AND EXPERIENCE:

Bachelor’s degree or Master’s degree in biology, biomedical science, or life science
One to three (1 – 3) years in a GMP environment required.
- Aseptic technique experience is required.
- Prior cell culture experience in a GMP facility is preferred.
Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
Experience with Enterprise Resource Planning (ERP) system, is a plus.

DESIRED KEY COMPETENCIES:

Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
Positive interpersonal skills.
Self-organizer, meticulous hands-on habits, keen attention to detail.
Ability to manage multiple and varied tasks and prioritize workload.
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
Proficient in MS-Word and MS-Excel.
Strong quantitative and analytical skills.
Ability to understand and execute on the company’s mission and values.
Maintain a high degree of ethical standard and trustworthiness.
Responsive, can-do attitude.
Deals with conflict in a direct, positive manner.
Ability to think and adapt to a rapidly changing environment and demands.

Apply Now Application ends in 27d 13h 50min

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