Manufacturing Specialist II

Manufacturing Specialist II

Location: Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate Job category: Manufacturing Target start date: 5/6/2024 Work Location: On-Site Shift: 1st

Place in the Organization

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 department Manufacturing 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.

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

Primary Role

The MFG Specialist in this role will be part of a cohesive team responsible for Deviation invesitgations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

Key result areas (major duties, accountabilities and responsibilities)

• Practices and promotes safe work habits and adheres to safety procedures and guidelines

• Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.

• Act as the Manufacturing lead for tech transfers

• Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.

• Facilitate cross functional teams to drive complex manufacturing operations changes or improvements

• Supports document revisions and/or document management including batch production records and manufacturing procedures

• Performs training with staff on the floor

• Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)

• Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

• Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.

• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion

• Reviews the work of others and provides feedback

• Creates and presents trending and metrics reports

• Participates in equipment start-up, commissioning, and validation activities

Qualification

• Normally requires 2 to 3 years related industry or manufacturing experience with a Bachelors degree. A Masters degree with 1 to 2 years experience will be considered as also acceptable.

• Some experience with owning, investigating, and writing deviations, creating and executing CAPAs, and writing and managing Change Controls.

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

• Some experience in biomanufacturing unit operations (USP and/or DSP)

• Good technical writing and oral communication skills

• Hands-on experience in writing and reviewing documentation

• Prior experience preferred performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)

Core competencies

• Ability to apply systems thinking as part of problem-solving

• Demonstrates industrial empathy when working with stakeholders

• Is detail oriented and able to self-organize

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

• Takes the initiative to own and resolve issues