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At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
Lead viral vector drug product manufacturing projects from concept to completion, including technology transfers, capital projects, campaign support, and process improvements. Manage CAPAs, deviations, change controls, validation review, and cross-functional collaboration. Mentor technicians, support manufacturing readiness and continuous improvement, and communicate project status and risks to stakeholders.
Summary Generated by Built In
Manufacturing Project SpecialistHouston, TXThe actual location of this job is in Houston, TX, US. Relocation assistance is available for eligible candidates and their families, if needed.This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.This role is primarily based on site. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case‑by‑case basis, in line with business needs.This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).What you will get:
- 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.
- Lead and manage viral vector manufacturing projects from concept to completion, including technology transfers, capital projects, campaign support, and manufacturing initiatives. Experience/knowledge in drug product operation and experiences in operation of filler machines preferred.
- 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.
- 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.
Skills Required
- 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 drug product and equipment
- Experience in technology transfer processes and campaign readiness
- Strong understanding of batch record procedures and manufacturing documentation
- Proficient in Quality Systems (e.g., deviations, change controls, TrackWise) with practical manufacturing application
- Knowledge of process, equipment, cleaning, and computer system validations; ability to review and approve protocols and support new equipment implementation
- Demonstrated ability to manage medium to large sized projects within required timeframes
- Exceptional written and verbal communication skills
- Collaborative team player, adaptable in fast-paced environments
- Demonstrates GMP and Safety role model behaviors
- Proficient in MS Project, Microsoft Word, Excel and PowerPoint
- Bachelor's Degree in Life Sciences, Biotechnology, or related field
- Experience/knowledge in drug product operation and operation of filler machines
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The Company
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
