Manufacturing Project Specialist

Lonza • Houston, TX

12d • Onsite

About The Position

The Manufacturing Project Specialist role is a fully site-based position in Houston, TX, US, with the flexibility to work remotely for up to 20% of the time (one day per week). This office-first role emphasizes close, real-time collaboration and technical precision in manufacturing medicines. The company offers an agile career, dynamic working culture, an inclusive and ethical workplace, and compensation programs that recognize high performance, along with a variety of benefits dependent on role and location.

Requirements

• Bachelor’s Degree in Life Sciences, Biotechnology, or a related field (preferred).
• 5-10 Years of experience in BioTech, Drug Product Manufacturing
• In-depth technical knowledge of small and large scale (50L, 250L and 2KL) viral vector manufacturing processes particularly in drug product, operations, and equipment
• Experience in technology transfer processes and campaign readiness.
• Strong understanding of batch record procedures and other essential documentation required for manufacturing execution.
• Proficient in Quality Systems (e.g., deviations, change controls, TrackWise etc) and practical application in manufacturing operations.
• Solid knowledge of process, equipment, cleaning, and computer system validations, with the ability to review and approve protocols and reports, and support new equipment implementation.
• Exceptional communication skills (both written and verbal) with the ability to clearly convey technical information.
• Collaborative team player with a high level of adaptability, capable of thriving in a fast-paced and dynamic environment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate sound decision making, considering broad scope of factors
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Embrace new challenges with a proactive and solution orientated mindset.
• Demonstrate a continuous improvement attitude.
• Lead and collaborate through changes with curiosity, ownership and accountability.
• Proficient in MS Project, Words, Excel and PowerPoint.
• Open to learning any new technologies, processes that are required for the role.

Nice To Haves

• Experience/knowledge in drug product operation and experiences in operation of filler machines preferred.

Responsibilities

• Lead and manage viral vector manufacturing projects from concept to completion, including technology transfers, capital projects, campaign support, and manufacturing initiatives.
• Own and drive improvement initiatives that align with department KPIs, focusing on quality, cost reduction, efficiency, innovation, on-time delivery, and right-first-time performance.
• Manage and monitor key processes such as CAPAs, planned deviations and change controls, to ensure compliance and timely closure.
• Collaborate cross-functionally with internal teams (MSAT, Engineering, Validation, PD, PM, Supply Chain etc.), customers, and manufacturing suites to develop or update policies, procedures, and best practices.
• Review deviation investigation reports, validation protocols as part of ongoing process and quality control.
• Monitor and support the timely closure of CAPAs and deviations, ensuring proper escalation and follow-up on overdue tasks.
• Provide leadership and mentorship to core technicians and other teams as applicable, including training impacted areas on new processes or procedures, particularly training of DP operation, filler machines.
• Ensure effective communication of project status, risks, and changes to stakeholders, ensuring alignment with overall project goals and objectives.
• Support manufacturing readiness, ongoing operations, and continuous improvement efforts.
• Perform other duties/projects as assigned.

Benefits

• Relocation assistance is available for eligible candidates and their families, if needed.
• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level