Pharmaceutical Manufacturing Technician

Pay: $25 - $28/Hour

Duration: 12+ months

Schedule Options:

• Sunday - Wednesday (7 AM - 5:30 PM)
• Wednesday - Saturday (7 AM - 5:30 PM)

This position will support the start-up and cGMP operation of the new cell therapy manufacturing facility. Collaboration is key, and you will work together frequently with Process Development, Clinical Operations, Materials Management, and Quality Teams.


Responsibilities:
• Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus 'right the first time'. Author and maintain bill of materials. Assist with batch record reconciliation and timely documentation. Documentation of all activities to meet cGMP requirements. Assist with deviations/non-conformances/OOS investigations.
• Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment.
• Train other personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks.
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as needed. • Participate in tech transfer activities. Support process development of platform processes, contributing to the plans and designs of studies/experiments. May modify or improve processes and systems, depending on purpose of experiments
• Provides technical instruction to the team and allocates administrative work where possible -assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues.
• Ensures a safe work environment in accordance with AstraZeneca standards.
• Weekend work may be required.


Education & Experience Requirements:
Bachelor's or Master's degree in life sciences, engineering, or a related field Experience: Bachelor's degree and 0-3 years of general cGMP manufacturing experience | Master's degree and 0-2 years of general cGMP manufacturing experience


Required Skills:
• Basic knowledge in biologics manufacturing process, cell culture and/or vector products.
• Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems.
• Working knowledge of automated manufacturing equipment and/or process analytical technologies.
• Proficiency in Microsoft Word, Excel and data analysis.


Desired Skills:
• Previous manufacturing or process development experience with cell therapy or vector products.
• Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.


Manager Top Must Haves:

• Good communication skills (will be working in different rooms and cross functionally so this is really important for success)
• Adaptability Aseptic technique/On the floor manufacturing experience

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