Specialist Manufacturing - Upstream DS

Specialist Manufacturing Associate

Join a dynamic environment as part of the Manufacturing Systems team supporting manufacturing activities through new product introduction, technology and equipment introduction, continual improvement projects, CAPA ownership, deviation trending, and optimization of single-use technologies.

In this vital role you will support drug substance manufacturing by executing production and process related changes in a large‑scale plant. You will own corrective and preventative projects, collaborate with cross‑functional teams to identify and implement solutions, and perform hands‑on runs, experiments and data analysis. Responsibilities also include defining and documenting operational practices, ensuring accurate documentation, implementing area improvements, commissioning equipment, design of experiments, and effective communication of findings.

• Support manufacturing by providing subject‑matter expertise for drug substance upstream as process owner (PPO).
• Lead cross‑function and complex projects using project management skills.
• Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process.
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
• Own quality records, such as CCMS, CAPA, and CAPA‑EV.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problem‑solving skills and champion continual improvement.
• Present to inspectors on areas of expertise.
• Mentor and train junior staff.
• Ability to be on‑site (flexible worker).
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function‑testing and project tasks with minimal disruption to operations.
• Must be able to work in a clean room environment wearing steel‑toe shoes, full clean‑room gowning, hairnet and gloves while following GMP documents (SOPs) with strict adherence to safety and compliance.

• Lead operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills.
• Provide assessment and advice on process impact for changes.
• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.

We seek a collaborative, team‑player partner who demonstrates the following qualifications.

• Doctorate degree.
• Master’s degree and 2 years of manufacturing and/or operations experience.
• Bachelor’s degree and 4 years of manufacturing and/or operations experience.
• Associate’s degree and 8 years of manufacturing and/or operations experience.
• High school diploma / GED and 10 years of manufacturing and/or operations experience.

• Degree in Engineering or Life Sciences.
• 3 years or more experience in drug substance GMP technical support roles, GMP manufacturing, engineering, process development, or equivalent.
• Technical knowledge of drug substance processing and a broad understanding of related disciplinary areas.
• Ability to navigate through ambiguity and identify and deliver on key milestones.
• Ability to advise and influence using experience and data.
• Ability to communicate complex technical information with internal and external colleagues at varying levels in presentation and technical writing forms.
• Ability to coach, mentor, and/or cross‑train colleagues within a core technical area.
• Team player – ability to support the process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
• Ability to drive results through leadership of cross‑functional teams.
• Experience in leading and managing projects.
• Understanding of single‑use technologies.
• Data analysis and/or data visualization skills.
• Excellent writing skills. Presentation…