2 Affinity Group Michaels Jobs

Job Type: Full-time

Pay: $25.00 - $37.00 per hour

The Pharmaceutical Manufacturing Technician role is critical to our patients. Manufacturing life-saving medicines right the first time for themselves and their team with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!

The Role:

• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
• Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
• May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
• Generate and revise internal and external documents (SOPs, BRs)
• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
• Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
• Recommend equipment and other supply purchases within the production areas
• Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
• Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
• Work closely with various departments and aid other teams as necessary
• Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
• Participate in facility expansion and equipment validation activities
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines

Downstream:

• Leverages knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing
• Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
• Perform buffer preparations, in-process sampling, formulation of bulk drug substance
• Conducts changeover and activation procedures for clean room suites and equipment
• Submits in-process and cleaning samples to Quality Control with required documentation
• Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
• Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)

Requirements:

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance

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