Director Process Development Purification Process - West Greenwich, RI

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On‑Site" at the location detailed in the job post.

Director Process Development – Purification Process Engineering

In this vital role you will lead the Purification Process Engineering function within Process development organization. You will be responsible for technical guidance of commercial Drug Substance operations within a high mix, multiproduct manufacturing facility. This includes technical transfer and scale up of processes, deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes. You will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality.

You will ensure that process engineering deliverables including new process introduction; implementation of new technologies;
Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed. You will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process, technology and capacity improvement opportunities. The Director ensures the group’s outputs are safe, compliant, and aligned with plant performance goals.

• Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations. Good knowledge of quality, regulatory, and development requirements for large molecule manufacturing.
• Support process scale‑up and technology transfer to production facilities. Partner closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
• Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
• Lead multi‑functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives.
• Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
• Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability.

• Bachelor’s degree and 10 years of Process Development, Engineering or Manufacturing experience
• Master’s degree and 8 years of Process Development, Engineering or Manufacturing experience
• Doctorate degree and 4 years of Process Development, Engineering or Manufacturing experience
• At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation. Managerial experience may run concurrently with the required technical experience.

• MS degree in Chemistry, Biochemistry, Biochemical or Chemical Engineering, or in a technological field.
• 10+ years of experience in pharmaceutical/biopharmaceutical process development or process support and current in Good Manufacturing Practices (cGMP) and global regulatory expectations.
• Ability to provide scientific and engineering expertise to multi‑functional teams in manufacturing, quality and supply chain to advance complex projects to completion and to interface on technical problem resolution.
• Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to multi‑functional audience and senior management.
• Detailed understanding of all stages of Process Validation lifecycle in biologics:
  Process Design, PPQ, Continued Process Verification (CPV).
• Understanding of quality attributes of large molecules and protein products and…