Technical Project Lead- Aseptic Manufacturing

4 weeks ago

Alnwick, United Kingdom CV-Library Full time

Are you ready to play a pivotal role in supporting cutting-edge aseptic manufacturing projects? We are recruiting on behalf of a leading pharmaceutical company for a Technical Project Lead to join their dynamic team. This position is critical to ensuring seamless production processes for Clinical Manufacturing Campaigns (CMC) and Clinical Trial Material (CTM) batches.

In this role, you will act as the operational bridge between manufacturing, quality assurance, and project management teams, ensuring every aspect of production is meticulously planned and executed.

Purpose;

* To coordinate preparation activities to enable manufacturing teams to deliver Aseptic projects (CMC and CTM batches)

* To work closely with Project Manager to maintain the manufacturing schedule

* To support smooth technical transfer in and out of manufacturing.

* Manufacturing support activities include:

*

* Timely ordering of all materials and components

* Preparation of manufacturing paperwork (Batch manufacturing records, Packing instructions etc)

* Attendance of Project meetings (client and internal) with Project manager and represent the manufacturing operations team.

* Support the conduct of internal, client and regulatory agency audits of the GMP product manufacturing capabilities

* This role is a manufacturing support/coordination role and is typically achieved outside of the cleanroom environment

* Working closely with QA to ensure quality standards are met

* Working collaboratively to utilise strengths and share knowledge across the wider business

Qualifications and experience;

* Degree or equivalent in a relevant scientific subject and/or knowledge and experience of pharmaceutical Aseptic manufacturing

* Experience managing complex projects with changing parameters

* Awareness of the current GMP regulatory environment

* Partnering with internal and external customers/stakeholders to deliver results

* Knowledge of the drug development process

Key attributes;

* Good written and oral communication skills

* Results driven

* Ability to plan, prioritise and adapt

* Excellent attention to detail

* Ability to work independently and as part of a team

* Forward thinking with a CI mindset

* Diligent

* Flexible and adaptable

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