Process Development Engineer II, Advanced Therapy Project Management (ATPM)

About the role

This representative will work in the Advanced Therapy Project Management (AT-PM) group within Product, Analytical, and Process Development Operations (PAPD Ops) to help drive successful development and tech transfer of advanced therapies (e.g., AAV, bioconjugates, and synthetic chemistry programs).

Responsibilities

• Lead cross-functional tech transfer teams and independently own workstreams to establish production processes at CDMOs.
• Drive readiness for manufacturing start-up and execution by clarifying scope, securing inputs/approvals, tracking deliverables, and escalating risks/issues with proposed mitigations.
• Own communication strategy and operating cadence for assigned programs (e.g., core team meetings, technical forums, and stakeholder updates). Provide concise, decision-ready status reporting (scope/timeline/cost/risk) tailored to different audiences, including senior stakeholders.
• Build, maintain, and continuously improve integrated plans across development and transfer activities. Facilitate scenario planning and tradeoff discussions to protect key milestones and support portfolio-level prioritization.
• Anticipate and address risks to manufacturing readiness related to process. Define mitigation plans and help ensure teams execute with rigor expected for successful CDMO campaign execution.
• Lead recurring and ad-hoc technical forums to drive timely decisions, resolve issues, and capture lessons learned. Translate learnings into tools to improve repeatability across modalities and CDMOs.
• Lead continuous improvement initiatives to mature AT-PM ways of working.
• Partner with procurement, finance, legal, and internal stakeholders to support CDMO engagement (RFPs, scope alignment, contracting coordination, and invoice tracking).

Requirements

• A B.Sc., with 5+ years of biochemistry/chemical/biochemical engineering or a related field, including demonstrated ownership of cross-functional deliverables.
• A strong customer-service mindset is essential.
• The ideal candidate can independently facilitate team collaboration, build and maintain integrated plans, and design/improve repeatable business processes.
• Experience supporting CMC development and/or technology transfer to CDMOs (e.g., process development, analytics, documentation readiness) is preferred.
• Prior experience or knowledge of bioconjugation, gene therapy/AAV, or related advanced therapy process development is a plus.

Qualifications

• Required Education: Bachelors Degree

Skills

• Problem Solving
• Strategic Thinking
• Communication
• Teamwork
• Process Improvement
• Stakeholder Management
• Project Management

Benefits

• Not specified

Pay

• $93,900.00 - $153,300.00 annually

Schedule

• Not specified