Pay: $75/HR to $90/HR (depending on years of experience)

Initial Contract Length: 1 year (has ability to extend and convert)

Job Description:

• 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.

Key Responsibilities:

• 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.

Qualifications:

• Bachelor’s degree in Chemical or Biochemical Engineering, or related engineering. 7+ years of experience
• Master's degree in Chemical or Biochemical Engineering, or related engineering. 5+ years of experience
• Ph.D. in Chemical or Biochemical Engineering, or related engineering. 3+ years of experience

Preferred Qualifications:

• 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.