Manufacturing Technician

Description

As a Manufacturing Technician, you will be part of a team responsible for the production of unique particles that enables improved and sustained growth of high-dose NK cells. You will also actively support development of process improvements and our next-generation manufacturing processes. As a key contributor to getting therapies to patients, there is a large focus on executing all activities in a timely manner with highest regard to quality, safety, health, and environment standards.

Responsibilities

• Prepare and execute manufacturing runs according to approved master batch records and standard operating procedures (SOPs).
• Ensure consistent process execution to guarantee high quality output.
• Ensure accurate completion of documentation associated with manufacturing, including documentation of any non-conformances or unusual results during manufacturing.
• Guard compliance to SOPs and relevant cGMP regulations during manufacturing.
• Keep the cleanroom/production area in an optimal state
• Collaborate with the Process Development team to facilitate development of manufacturing steps.
• Support Process Development with preparation, execution, and documentation of process development studies.
• Support tech transfer activities.
• Function as Back-up person for the warehouse assistant – taking deliveries, sending shipments, storage of delivered goods and administrative tasks.
• Support investigations, root cause analyses and/or implementation of process changes resulting from manufacturing non-conformances or continuous improvement activities.

Qualifications & Education

Someone with good proficiency of biological manufacturing processes, media/buffer preparations, and ideally aseptic/sterile techniques is required. In addition, we are looking for someone with the following requirements:

• BSc or MSc in cell biology, biotechnology, bioprocess technology or a related field.
• Minimum 2 years of working experience in a relevant field, preferably in industrial cell therapy, vaccines, or upstream biologics manufacturing.
• Hands-on experience with cell culture, ideally including experience with relevant process equipment.
• Available to work on some weekend days on a regular basis and being available for regular on-call service.
• Ability to comply with applicable procedures and regulations; Good understanding of GMP and/or experience in GMP production is a plus.
• Excellent planning and organizing skills.
• Excellent team player and communicator.
• Strong sense of quality and ownership.
• Professional proficiency of the English language, written and verbal. Other languages especially Dutch are a plus.

To apply contact Kevin Cronin on +353 87 162 9928.

Email CVs to kcronin@mile.ie