Manufacturing Project Specialist

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 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.

The full list of our global benefits can be found here:

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 Bio Tech, 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, Track Wise 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 time frames.

* Demonstrate sound decision making, considering broad scope of factors

* Ability to work inter-departmentally and with customers.

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