Technician I, GMP Manufacturing Support - Buffers (3rd Shift)

About The Role

The Technician I, GMP Support – Buffers, performs a wide range of functions crucial to AAV gene therapy production. This position is responsible for contributing to buffer and media formulation. This entry-level position offers an opportunity to gain foundational experience in the multifaceted support activities crucial for the production of AAV gene therapy products.

Responsibilities

• Assist in media and buffer preparation under supervision, adhering to schedules, and maintaining accurate documentation to ensure compliance with SOPs and cGMP regulations.
• Maintain real-time and accurate documentation; perform the manufacturing review of logbooks, MPR's, and associated documents.
• Assist in troubleshooting and resolving minor equipment or process-related issues under the guidance of senior team members.
• Collaborate with cross-functional teams, including GMP Manufacturing, Quality Assurance, Quality Control, and Product Development, to support efficient manufacturing operations.
• Assist in equipment setup, inventory management, and material requests for cleaning and manufacturing activities.
• Adhere to strict GMP gowning procedures, including the use of sterile coveralls, boots, hair net, face covering, goggles, and gloves to prevent contamination and ensure compliance with regulatory standards for cleanroom environments.
• Contribute to process improvement initiatives, providing feedback and suggestions to enhance department-related processes and improve efficiency.
• Follow safety procedures and maintain a clean workspace.

Qualifications

• High school diploma or equivalent required.
• Experience following SOPs or other protocols/work instructions.
• Basic computer skills and the ability to learn and use manufacturing software.
• Ability to work the hours necessary to support production and/or product transfer activities.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) as needed.
• Ability to work a 3rd shift: 4 x 10-hour schedule (beginning Sunday night and ending Thursday morning), with the flexibility for occasional overtime as needed.

Preferred Skills

• Prior experience in a regulated-manufacturing or laboratory environment.
• Exposure to facility or equipment cleaning and sanitization, media and buffer preparation, or equipment building and setup.

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.

Benefits

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
• A competitive paid time off plan.
• 12 weeks of fully paid parental leave.
• Annual bonus opportunities for all full-time team members.
• 401(k) with company match.
• Special employee discounts, including childcare and dependent care savings.
• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage.
• A fully stocked kitchen with free snacks and beverages.
• Ongoing professional development resources, training, and mentorship programs.