Biomanufacturing Associate

POSITION SUMMARY

We are seeking a Biomanufacturing Associate for a manufacturing role to start-up and run day to day operation of GreenLight’s cGMP manufacturing operations in Lexington, MA. This individual will initially assist in the installation and qualification of biomanufacturing equipment leading into the production GMP materials in support of GreenLight’s portfolio. They will be tasked with being part of a dynamic manufacturing team scaling up and producing RNA material under GMP conditions in support of Clinical operation. The position offers growth potential for a very experienced manufacturing associate or someone just starting off their Biotech career with a growing biomanufacturing team within a growing company.

MAJOR RESPONSIBILITIES

This associate role is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance through to commercial processing. Initial focus is on the start-up of a new facility with new equipment by performing commissioning and qualification activities, creation of cGMP documentation (i.e., Batch Records, SOPs) and training within the production area.

• Aid in the installation, and qualification of respective bioprocessing equipment.
• 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.
• 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.
• Supports company and regulatory inspections as needed.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Professional certifications in relevant cGMP bioscience
• Worked in GMP biomanufacturing operations or within a laboratory environment, with 1 to 4 years' experience in the field.
• Familiarity with Fermentation and or Purification bioprocessing equipment
• Ability to follow Safety requirements, Standard Operating Procedures, and essential communication skills.
• Strong mechanical aptitude and ability to interface with computerized systems required systems (i.e., Unicorn, DeltaV, Scada) and supporting business systems (i.e., Microsoft Teams, Quality and Document Management Systems etc.).
• Demonstrated capability to work as a 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 and or with other cross functional groups.
• Must be able to work in a clean room environment and able to lift up-to 25lb.
• Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout manufacturing area.

EDUCATION

• HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent