Senior Process Engineer - Tech Transfer & Manufacturing Readiness

Position Summary

The Senior Process Engineer is a key technical leader responsible for supporting the successful transfer, fit assessment, and lifecycle optimization of monoclonal antibody (mAb) and antibody-drug conjugate (ADC) processes within a CDMO manufacturing environment. This role partners closely with MS&T, Plant/Facilities Engineering, and Capital Project Engineering to ensure manufacturing readiness, effective facility fit, and robust process performance.

The position requires deep expertise in bioprocessing operations and a strong understanding of equipment design, facility capabilities, and capital project execution to enable seamless delivery of client programs from tech transfer through commercial manufacturing.

This role directly enables:

• • Successful onboarding of new client programs
  • Efficient capital deployment and facility utilization
  • Robust, scalable, and compliant manufacturing processes

Duties & Responsibilities

• • Lead facility fit assessments for incoming customer processes (mAbs and ADCs), evaluating compatibility with existing equipment, utilities, and facility constraints.
  • Collaborate with MS&T and customer-facing teams to translate process requirements into facility and equipment needs.
  • Identify and mitigate risks associated with scaling, containment (for ADCs), and process integration into existing operations.
  • Develop technical gap analyses and recommend solutions, including equipment modifications or capital investments.
  • Serve as a technical bridge between MS&T, Manufacturing, Facilities Engineering, and Capital Projects.
  • Partner with MS&T to ensure process understanding supports equipment selection and operational readiness.
  • Work with Plant/Facilities Engineering to ensure utility systems and infrastructure align with process demands (e.g., HVAC, clean utilities, containment systems).
  • Support Capital Project Engineering by defining process requirements, user requirement specifications (URS), and design inputs.
  • Provide process engineering expertise for new equipment installations, expansions, and facility upgrades.
  • Support project phases including conceptual design, detailed design, FAT/SAT, commissioning, and qualification.
  • Review P&IDs, layouts, and equipment specifications to ensure process compatibility and operational efficiency.
  • Contribute to capital project risk assessments, cost evaluations, and scheduling considerations.
  • Develop, lead and/or review technical documents including User Requirement Specifications (URS), process descriptions and flow diagrams, engineering assessments and gap analyses, change controls and deviation investigations, ensuring compliance with cGMP, regulatory standards, and internal quality systems.
  • Drive continuous improvement of upstream, downstream, and ADC processing equipment for efficiency, reliability, and throughput.
  • Evaluate and implement improvements in areas such as single-use systems (bioreactors, mixers, filtration), chromatography systems, high-potency compound containment systems (for ADCs).
  • Troubleshoot process bottlenecks and equipment performance issues in collaboration with Manufacturing and MS&T.
  • Support tech transfer activities by ensuring facility and equipment readiness.
  • Provide on-the-floor technical support during engineering runs, PPQ, and commercial manufacturing.
  • Ensure tech transfer process alignment with GMP expectations and internal standards.

Education & Experience

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field (Master’s preferred).
• 8+ years of experience in biopharmaceutical manufacturing, process engineering, or MS&T, preferably within a CDMO environment.
• Proven experience with mAbs and/or ADC processes.

Knowledge, Skills, Abilities

• Strong knowledge of upstream and downstream bioprocessing, ADC manufacturing and high-potency containment strategies, bioprocess equipment design and scale-up
• Experience with facility fit assessments and technology transfer, capital project execution and engineering design support, single-use/stainless/hybrid manufacturing platforms, and scale-up analysis.
• Strong cross-functional collaboration and communication skills.
• Ability to translate complex process requirements into engineering solutions.
• Problem-solving mindset with a focus on risk mitigation and practicality.
• Experience working in fast-paced, multi-client CDMO environments.
• Project management and technical leadership capabilities.
• Experience with high-containment facilities and occupational exposure controls (OEL/OEB frameworks) preferred.
• Exposure to commercial manufacturing and lifecycle management.
• Knowledge of automation, process control systems (DeltaV, etc.), and digital manufacturing tools.

Physical Demands

• Physical demands of the job include unassisted lifting of items, not to exceed 50 lbs; crouching/squatting; kneeling; sitting; crawling; walking on level surfaces; climbing stairs and ladders; and vision (visual inspection of installations). The job will also require the use of PPE, such as hard hat, hearing protection, safety glasses, steeled toed shoes, fall protection, and electrical safety gear.

Work Environment

• Work environment for the job include office space, lab space, inside work, outside work, working alone, working with and around others, noise, heights, and cramped quarters.

Travel

This role may require up to 10% travel.

Target Bonus

16%

Work Location:

East Syracuse, NY 

New York Pay Range 91000 - 142000 USD