Production Specialist- Protein and Enzyme

About the role:

We are seeking an outstanding biochemist to join the Manufacturing team to support the production of custom biological reagents. This is a unique cross-disciplinary position that will work closely with a variety of groups including New Product Development, QC/QA, and Planning to produce protein and enzyme reagents for the rapid expansion of 10x product lines. Candidates must possess expert-level knowledge of both upstream and downstream protein and enzyme production processes within a regulated manufacturing environment. Additionally, they should be able to apply this knowledge creatively and independently in a fast-paced work setting. The successful applicant will have exceptional attention to detail and the ability to meticulously write, execute and analyze complex Standard Operating Procedures.

Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating at all levels within the organization and provide immediate contribution.

What you will be doing:

• Provide hands-on leadership in bacterial fermentation (10-20L), harvesting, and purification of recombinant proteins for molecular biological workflows.
• Subject matter expert and lead technical resource for protein reagent process transfers from Product Development to Manufacturing.
• Participate in the day-to-day management of the protein production lab.
• Help in leading infrastructure requirements to build out internal manufacturing capabilities.
• Process and knowledge transfer to production staff through documentation and hands on training

Minimum Requirements:

• BS or MS with 10+ years or PhD with 5+ years industry experience in expressing, purifying, and analyzing enzymes and proteins relevant to molecular biology workflows.
• Strong technical knowledge and direct hands-on experience with pilot and production scale processing operations such as fermentation, chromatography, tangential-flow filtration, centrifugation, formulation, etc.
• A solid enzymology background is essential.
• Understanding engineering issues related to medium- to large-scale processes and applying both practical and analytical skills for troubleshooting and conducting root cause analyses.
• Sound understanding of protein biochemistry, recombinant protein expression in microbial hosts, and molecular biology of life science enzymes, proteins and formulations.
• Solid protein analytical experience such as SDS PAGE, HPLC, MS, etc.
• Hands-on experience with AKTA chromatography systems for protein purification workflows using and operating Unicorn software packages.
• Hands on experience with 10-20 liter bioreactors for use in bacterial fermentation
• Demonstrated a successful track record of transferring technologies from late research stages to manufacturing scale workflows.
• Proven ability to draft Batch Records and Work Instructions; and effectively train junior staff to perform these tasks successfully.
• Exceptionally strong collaboration and communication skills.
• Familiarity with ERP systems, inventory management, work orders, and non-conformance reporting.
• Ability to perform physical activities such as bending, lifting, reaching and standing for extended periods.
• Must be able to lift and carry items weighing up to 25 lbs.
• Use personal protective equipment (PPE) as required to maintain safety in manufacturing and lab areas
• Must be able to work safely with chemicals and hazardous materials
• Must be able to work onsite 100% of time. 

Preferred skills/experience:

• Experience in an ISO 9001 or higher manufacturing setting and good documentation practices.
• Previous experience with custom and/or novel protein formulations including experience with antibodies and lyophilization.
• Strong project management skills to lead initiatives aimed at process improvements.

#LI-MH1 #on-site