Downstream Development Engineer Pilot Operations

Overview

The Downstream development engineer will support Pilot lab operations within R&D that serves as the critical interface between lab-scale development and full-scale manufacturing. The individual will independently execute both routine and complex operations, participate in planning unit operations/experiments, draft support documentation (SOPs, batch records, and/or reports), and analyze data (Spotfire or similar). They will apply knowledge from various technical areas, industry practices, and standards, and will provide quality and productive output that is consistently timely, reliable, and reproducible.

The candidate should possess experience and knowledge of activities routinely performed in downstream (e.g. Harvest Clarification, Chromatography, Filtration, and buffer preparation). Previous experience with AKTA systems and Unicorn Software is preferred. Additionally, knowledge of Upstream Purification activities (e.g. vial thaw, cell culture expansion, large scale bioreactor setup and control, centrifugation/depth filtration, and media/buffer preparation) is appreciated. This role is predominantly lab-based and will interact closely with counterparts in Process Development and Manufacturing Sciences to support tech transfer of developed/locked processes.

80% - Pilot-Scale Cell Culture Campaigns:

• Execute non-GMP Downstream Purification operations at pilot scale (50-1000L) to support new product development, material supply, process improvements, and demonstration runs for various programs across the whole development lifecycle, including post-launch commercial processes.
• Partner with other process development and manufacturing sciences teams to troubleshoot and resolve process challenges and support large-scale studies.
• Coordinate and manage critical process details, including long-lead item tracking, sample planning, material ordering, and vendor interactions.
• Independently record, analyze, and interpret process data, identifying patterns and trends.
• Present findings and technical issues at departmental and project meetings, proposing solutions and implementing corrective actions under supervision.
• Contribute to pilot-scale procedures and documentation.
• Support global tech transfers.
• Support the authoring of technical reports, protocols, and internal presentations. Assist team members with scientific publications, external abstracts, and conference presentations as required.

20% - Technology and Digital Innovation:

• Evaluate and integrate novel pilot-scale technologies and digital tools to establish a versatile platform supporting multiple bioprocesses.
• Drive continuous improvement through the adoption of innovative solutions to enhance efficiency, data analytics, and operational performance.

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related pharmaceutical science with 2+ years of relevant industry experience
  , OR a Master’s degree in related fields (industry experience preferred but not required).
• Experience with downstream purification processes is required.
• Hands-on experience with downstream activities such as chromatography, ultrafiltration/diafiltration (UF/DF), tangential flow filtration (TFF), and depth/sterile filtration.
• Experience supporting non‑GMP batches within an R&D Pilot Plant environment operating at the 50–1000 L bioreactor scale (interface between lab-scale and full-scale GMP manufacturing).
• Experience with AKTA chromatography systems and Unicorn software preferred.
• Strong analytical and problem-solving abilities; able to troubleshoot technical issues using data and scientific judgment.
• Effective collaborator with the ability to work well within cross-functional teams.
• Clear and concise communicator with strong documentation practices and the ability to escalate issues appropriately.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Proficient in operating and maintaining relevant laboratory equipment; familiarity with upstream processes is a plus.
• Ability to wear required PPE (safety glasses/goggles, gloves, safety shoes).
• Ability to lift, push, or pull up to 25 lbs
  , stand for up to…