Scientist III

Job Description

Job Summary:

• Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes.
• Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
• Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
• Anticipate, respond to, and permanently resolve issues that arise during production.
• Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
• Lead the creation and use of digital process data analytic systems.
• Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Responsibilities:

The Process Engineer IV role is expected to:

• Provide technical leadership in area of responsibility.
• Provide technical/scientific support, expertise, and guidance to manufacturing and quality.
• Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.
• Lead technical project team or cross-functional team between groups/organizations.
• Provide input and coordinates support from process development teams.
• Review manufacturing processes and/or development and production data.
• Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.
• Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
• Provide CMC support and guidance for product life cycle management.
• Attend trainings and scientific meetings to remain current with technology and regulatory guidelines.
• Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

Education and Experience:

• Bachelor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry.
• Master’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry.
• Doctor’s Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 3 years of relevant experience in the biopharmaceutical or pharmaceutical related industry.

Qualifications Requirements:

• Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.
• Experience with biologics downstream unit operations, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.
• Understand cGMP concept and familiar with quality and regulatory framework.
• Proficient in process data analytics
• Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.
• Experience leading projects and/or cross functional teams.
• Works independently with minimal supervision and direction.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Ability to navigate ambiguous circumstance to meet final objectives.
• Strong communication and technical writing skills.
• Experience communicating with business partners and senior management.

Working conditions:

• Ability to gown and Product entry to manufacturing areas.