Job Details

The Biomanufacturing Associate II plays an integral role within the gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.

This role will apply solid knowledge and experience across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols.

Key Responsibilities and Duties:

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Effectively execute a range of tasks, in line with SOPs, in the following area:
  • Upstream Activities (e.g., solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest).
• Follow instructions when performing planned manufacturing activities, in alignment with the batch record.
• Prepare, edit, and complete quality documents. Well-versed in applying GDP.
• Ensure data integrity – accurately document and review work prior to submission.
• Document, record, investigate, and report observed process variances/deviations, in real time.
• Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools.
• Troubleshoot routine issues, using root cause analysis.
• Propose and implement approved improvements.
• Create and implement safety practices, assist others, and report all incidents immediately.
• Adhere to safe working practices and comply with site-based guidelines by applying:
• Cleanroom and aseptic behaviors and procedures.
• Proper Personal Protective Equipment (PPE) and gowning requirements.
• Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc.
• The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
• An understanding of biosafety levels and applying specific controls.
• Universal precautions with respect to OSHA guidelines.
• Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.
• May assist others.
• Ensure 100% on time completion of training plan.
• Be punctual and flexible with work schedule, tasks, etc. to support business demands.
• Perform other responsibilities as required.

Qualifications:

• HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience. Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc. Willing to become a qualified LEAN trainer.
• Able to work in accordance with the companies Values.
• Foster collaboration – is a team player, with a positive attitude, professional tone, and demeanor.
• Is accountable and delivers high quality work on time.
• Willing to continuously learn and improve.
• Strong attention to detail, can recognize deviations, and has solid GDP skills.
• Solid analytical, critical thinking, problem-solving and communication skills.
• Solid knowledge/application of Word, Excel, Teams, databases, etc. Willing to learn PowerPoint.
• Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.