Biomanufacturing Lead

POSITION SUMMARY

We are seeking an experienced Biomanufacturing Associate for the Lexington, MA facility who can assume the lead role for the start-up and day to day operation of GreenLight’s cGMP manufacturing operation. This individual will assist in the installation and qualification of biomanufacturing equipment for GMP production.  They will also be tasked with helping to lead a team of junior manufacturing associates ensuring the success of day-to-day operations of the manufacturing processes. The position offers growth potential for an experienced associate to join the growing biomanufacturing team within a growing company. 

MAJOR RESPONSIBILITIES

The senior associate / lead role is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance through to commercial processing in support of the GreenLight Bioscience portfolio. Initial focus is on the start-up of a new facility, support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation.  

• • Aid in the installation, and qualification of respective bioprocessing equipment. 
  • Participate in the Tech Transfer of mRNA and other biopharmaceutical processes into the manufacturing suite. 
  • Assist in the scheduling and daily manufacturing activities to maintain that schedule. 
  • Participate in the creation of cGMP manufacturing SOPs and Batch records. 
  • Execute upstream and downstream; Fermentation, TFF and Chromatography processes in a GMP environment. 
  • Troubleshooting and assist in the resolution of manufacturing deviations and identification of root cause when required. 
  • Ensures the operations in the manufacturing suites are performed in a manner that secures the safety of his fellow associates and in accordance with the cGMP production standards. 
  • Assist in the identification of process improvements to enhance ease of operation and reduce errors. 
  • Work with tech transfer and QA to ensure the adherence to GMP principals in the manufacturing areas. 
  • Supports company and regulatory inspections as needed. 

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Minimum 3 years in cGMP biomanufacturing or laboratory environment 
• Experience with Fermentation and or Purification bioprocessing equipment.  
• Experience with mRNA IVT and LNP processing
• Strong problem solving and communication skills essential. 
• Ability to follow Safety requirements, Standard Operating Procedures, and work under minimal supervision.  
• Strong mechanical aptitude and ability to interface with computerized systems required systems (i.e., Unicorn) and supporting business systems (i.e., Microsoft Teams, Quality and Document Management Systems etc.). 
• Demonstrated capability to work as a lead for team member in a matrix manufacturing team. 
• Ability to multitask, time management and prioritize activities.  
• Demonstrated capability to work independently, as a team member in a matrix manufacturing team with other cross functional groups.  
• Must be able to work in a clean room environment to lift up-to 25lb.  
• Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout GMP manufacturing area. 

EDUCATION

• HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent preferred. 
• Professional certifications in relevant cGMP bioscience activities.