Bioprocess Technician II - Manufacturing

Pick a challenge that is bigger than your lifetime.

New ideas are all around us, but only a few will change the world. That’s our focus at Nutcracker. We are an early-stage company looking at mRNA and its production in a completely different way. We are challenging the conventional and merging both innovative science with engineering to not just save lives, but to improve the manufacturing and delivery of critical health solutions. Yes, as our name implies, we are working to crack some of the toughest scientific and engineering nuts out there. If you are driven to discover, create, and inspire something that moves science and technology forward, and lasts a lifetime and beyond, you’re ready to be a Nutcracker.

In Summary, You Will

Work on delivery of innovative mRNA therapy products. The role interacts with cross-functional teams to deliver relevant documents, technical assessments, and manufactured products that meet necessary quality, cost, and cycle time objectives. Daily duties will include owning and running microfluidic-based equipment and manufacturing batches, archiving data associated with manufacturing, and communicating with cross-functional teams and internal management.

Responsibilties

• Dispense materials and manufacture GMP, developmental, and clinical study supplies using Nutcracker's proprietary microfluidic-based platform.
• Maintain the GMP/ manufacturing areas in an inspection-ready state; perform monthly equipment cleanings, keep manufacturing areas organized and stocked with consumables.
• Manages hazardous waste appropriately and escalates issues with waste management.
• Implement robust processes and maintain reliable relationships with cross-functional teams to deliver products on time.
• Follows robust, GMP-appropriate documentation practices and prompt data entry into systems designated by management
• Performs accurate material transactions into the ERP system as appropriate per procedure
• Troubleshoot equipment issues and set preventative measures. Document changes and provide issue escalation to the right level, as appropriate.
• Documentation: identify gaps in production records and processes, is able to suggest/ drive changes in written procedures
• Provide process monitoring: Track manufacturing process and equipment performance. Suggest improvements for process and equipment.
  
  

Requirements

• Minimum of 2 years of biotech/pharma or aseptic manufacturing and development operations related experience preferred.
• Knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
• Ability to function in a fast-paced small company environment with minimal direction and ability to adjust workload based upon changing priorities.
• Ability to think critically with demonstrated troubleshooting and problem-solving skills.
• Excellent computer skills, MS Office proficiency.
• Excellent interpersonal, verbal and written communication skills.
• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline is a plus, but not required.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
  
  

$43.50 - $47 an hour

The expected range for Bioprocess Technician II - Manufacturing is $ 43.50 to $ 47.00 per hour based on candidate experience, education, location, and other job-related factors.