Lonza America Inc

Manufacturing Project Specialist

Lonza America Inc • $80K — $110K *
Houston, TX 77084In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Life Sciences, Biotechnology, or related field preferred.
  • 5-10 years of experience in BioTech and Drug Product Manufacturing.
  • In-depth technical knowledge of small and large scale viral vector manufacturing processes.
  • Experience in technology transfer processes and campaign readiness.
  • Strong understanding of batch record procedures and essential documentation.
  • Proficient in Quality Systems and their application in manufacturing operations.
  • Exceptional written and verbal communication skills.

Responsibilities

  • Lead and manage viral vector manufacturing projects from concept to completion.
  • Drive improvement initiatives aligned with department KPIs.
  • Manage key processes like CAPAs, planned deviations, and change controls.
  • Collaborate with internal teams and customers to develop or update policies and procedures.
  • Review deviation investigation reports and validation protocols.
  • Monitor the timely closure of CAPAs and deviations and ensure proper escalation.
  • Provide leadership and mentorship to technicians and train on new processes.

Benefits

  • Relocation assistance available for eligible candidates and families.
  • Flexibility for remote work up to 20% of time, considered on a case-by-case basis.
  • Supportive team environment fostering real-time collaboration.
Full Job Description
Manufacturing Project Specialist
Houston, TX

The 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 do:
  • 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.

What we are looking for:
  • 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.

About Lonza America Inc

Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
Learn more about Lonza America Inc
Size
16,218 employees
Industry
Business Services
NASDAQ
LZAGY
* Ladders Estimates

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