Manufacturing Technician I

Manufacturing Technician I

Location: Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate Job category: Manufacturing Target start date: 6/24/2024 Work Location: On-Site Shift: 1st

uni

Qure is dedicated to bring therapies for unmet medical needs to patients. In doing so each function in uni

Qure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The Manufacturing department has an important role regarding the quantity and quality of our AAV-based products. cGMP is applied to manufacture and verify the quality of our products to ensure (i) proper delivery and functionality as well as (ii) safety. Those activities are supporting the whole scope of AAV product and process development. By strict application of cGMP guidelines, monitoring and qualification of our manufacturing environment and systems, the manufacturing of drug substance and drug product is performed.

Place in the Organization

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC, QA, Engineering and Validation.

With direct supervision this individual will perform routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products in their assigned areas. This position is located in Lexington, MA and reports to the MFG Supervisor.

Key result areas (major duties, accountabilities and responsibilities)

Perform manufacturing of uni

Qure's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records. Primary responsibilities include the following:

• Attend daily morning meetings

• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state

• Maintaining orderliness of process area and stocking production area with supplies

• Demonstrating general knowledge of aseptic techniques

• Support troubleshooting activities, working with more senior-level team members to resolve according to SOPs

• Execute routine and non-routine production operations according to MFG schedule

• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms

• Perform page reviews in BPRs, SLRs, Logbooks, and Forms as needed

• Carry out work in a safe manner, notifying management of safety issues and risks

• Maintain up-to-date training folder for applicable processes

• May be required to work at least four holidays in the calendar year

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment and clean room

• Perform standardization of equipment

• Assist in the assembly and disassembly of process equipment

• Escalate work requests to Senior or Lead Technicians for submission in work request management system

Staff Technical Training and Development:

• Propose document revisions

• Escalate process improvement ideas

• Develop and maintain personal development plan

• Provide annual performance self-assessment

Qualifications:

• Normally requires a high school diploma and 0-2 years related industry experience or an Associates Degree in Life Sciences/Engineering field. Biotech Certificate preferred

• Good writing and oral communication skill

• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization

• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures

• Applies experience and skills to complete assigned work within own area of expertise

• Works within standard operating procedures and/or scientific methods

• Comfortably able to lift up to 40lbs

Core competencies:

• Has a process-oriented way of thinking and working

• Is detail oriented

• Is self-organized

• Has a flexible attitude in a challenging environment

• Is able to communicate in professional way on diverse levels and channels

• Is intrinsically motivated