Process SME (Biologics / Chemical Engineering)

Job title: Process SME (Biologics / Chemical Engineering)

Location: Frederick, MD / Gaithersburg, MD (open for relocation)( ~60% On‑Site)
Duration: 20 Weeks (project expected to continue through 2029)

Client – Confidential

Mod of interview – Video

Overview

This role serves as the Process Subject Matter Expert (SME) supporting a long-term biologics manufacturing program focused on monoclonal antibody (mAbs) processes. The SME provides technical leadership through concept design, process development, technology transfer, scale-up, and ongoing optimization for upstream and downstream biologics operations. The position includes oversight of engineering deliverables, design review, lifecycle considerations, and collaboration with cross-functional teams to ensure that process, safety, and compliance expectations are met throughout all project stages.

Key Responsibilities

• Act as the primary Process SME for biologics manufacturing, including upstream and downstream mAbs operations.
• Support process design, optimization, troubleshooting, tech transfer, and scale‑up activities.
• Participate in concept design, including development and review of Heat & Material Balances and Concept Design Reports.
• Attend design workshops, provide technical feedback, and guide A&E partners throughout the design effort.
• Review major engineering deliverables such as concept packages, HAZID outputs, and design revisions.
• Provide input into process validation strategy, documentation, and regulatory-aligned approaches.
• Partner closely with Engineering, Manufacturing, MSAT, Quality, and Operations teams.
• Manage process-related standards, requirements, and operational best practices for incorporation into engineering packages.
• Support the development of P&IDs and user requirement specifications (URS) for biologics unit operations (e.g., bioreactors, TFF systems).
• Participate in supplier evaluations and recommendations for critical equipment.
• Ensure design compliance with GMP, safety, and engineering standards.
• Conduct periodic design assurance reviews and produce design assurance reports.
• Provide technical support across commissioning, qualification, and early operations, including review of FAT/SAT, DQ, IQ, and OQ documentation.
• Support risk assessments, lifecycle cost considerations, equipment interface alignment, and digital/data requirements.
• Contribute to procurement strategy, contract technical scope, and interface management across system packages.
• Maintain consistent on‑site engagement (60% weekly) at designated engineering offices.

Soft Skills & Expectations

• Strong collaborator with the ability to challenge constructively and maintain effective cross-functional relationships.
• Detail-oriented problem solver with a results-driven mindset.
• Clear communicator capable of influencing technical and operational stakeholders.
• Able to lead through ambiguity and guide teams in a complex project environment.
• Maintains high professional standards and integrity under demanding timelines.

Required Qualifications

• Bachelor’s degree in Chemical Engineering (advanced degree preferred).
• 10–15+ years of biologics process engineering experience.
• Demonstrated expertise in monoclonal antibody manufacturing.
• Strong technical troubleshooting skills and experience with GMP environments.
• Ability to work full-time and begin on March 9.
• Comfortable with long-term programs and high-paced project environments.