AllianceBio (A-BIO) is seeking a results-driven technical operations leader to drive strategic, high-impact client engagements across biologics, gene therapy, and cell therapy programs. The ideal candidate will have experience in manufacturing operations, quality systems, risk mitigation, and startup strategy across a range of modalities and technologies.
Preferred location in North Carolina, Philadelphia/NJ, or Maryland. On-site engagement expected (50–80%) with travel requirements of 20–25%.
You will lead a team of consultants and technical operations experts focused on manufacturing start-up, compliance, process risk management, and operational excellence. You will interact with A-BIO and client leadership in a seller-doer capacity driving strategy and managing resource loading.
• Serve as a seller-doer maintaining ~80–85% billability while driving delivery and securing new client opportunities.
• Develop standard ways of working and playbooks for service offerings that can be tailored to any client situation.
• Design and implement manufacturing, QC and supply chain operations (MFG) readiness programs, including SOP development and operator workflows.
• Lead and facilitate facility and process risk assessments to proactively identify operational gaps and mitigation strategies.
• Perform compliance gap assessments and recommend quality system remediation plans aligned with regulatory expectations.
• Support clients in quality management system (QMS) setup, including deviation management, document control, and QA operations integration.
• Guide the design and implementation of single-use technologies, including closed system workflows and contamination control strategies.
• Direct aseptic processing design initiatives to meet manufacturing needs across diverse therapeutic platforms.
• Coordinate operational startup, scale-up, and shutdown execution in both greenfield and retrofit environments.
• Lead cross-functional collaboration across engineering, CQV, supply chain, and quality functions.
• Mentor and develop A-BIO team members, contribute to capability-building, and shape the future of A-BIO’s delivery playbook.
• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• 10–20+ years in biopharma manufacturing, MS&T, or technical operations.
• Demonstrated experience in facility startup, CQV, QMS integration, and MFG operations.
• Strong working knowledge of GMP regulations, manufacturing SOPs, and QA/QC requirements.
• Ability to lead teams across the technical lifecycle—from design to execution and ongoing operations.
• Excellent stakeholder communication and presentation skills.
• U.S. work authorization and willingness to travel 20–25%.
• Experience with commercial launches, FDA/EMA readiness, and remediation programs.
• Familiarity with process risk assessments, gap analyses, and regulatory audits.
• Familiarity with developing and implementing automated manufacturing solutions such as electronic batch records
• Involvement in industry associations such as ISPE, PDA, or BioPhorum.
A‑BIO exists to help clients bring life‑changing therapies to patients while fostering a workplace where our people thrive. Join a firm growing rapidly year‑over‑year and shape the systems, culture, and offerings that will define the future of technical project management in life sciences.
