Downstream Manufacturing Associate

7 days ago

Columbus, Ohio, United States Forge Biologics Full time
About the Role

We are seeking a highly skilled and detail-oriented Gene Therapy Manufacturing Specialist to join our team at Forge Biologics. As a key member of our manufacturing team, you will play a vital role in the production and purification of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations.

Key Responsibilities
  • Perform routine downstream manufacturing operations, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
  • Prepare and operate equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring they are properly calibrated and maintained.
  • Execute purification processes for AAV-based gene therapy products, adhering to cGMP guidelines and maintaining a clean and organized work area.
  • Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner.
  • Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
  • Assist in the execution of process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
  • Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment.
  • Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.
Requirements
  • Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
  • Strong attention to detail and the ability to follow written procedures and protocols accurately.
  • Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
  • Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
  • Ability to adapt to changing priorities and work independently as well as part of a team.
  • Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.
Preferred Skills
  • Familiarity with purification techniques and equipment commonly used in downstream bioprocessing, such as chromatography systems, filtration systems, and TFF systems.
  • Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.
Work Environment and Physical Demands

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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