Api (Lant/bas) Pharmaceutical Process Experts

2 weeks ago


Wrexham, United Kingdom IPSEN Full time

**Title**:
API (LANT/BAS) Pharmaceutical Process Experts

**Company**:
Ipsen Biopharm Ltd
- Are you looking for an interesting role leading the technical transfer of new products into commercial API manufacture?_

If so, we are currently recruiting for several API (LANT/BAS) Pharmaceutical Process Experts to join our Manufacturing Team. These positions are permanent and based at our Wrexham site.

The successful applicant will have experience in GMP pharmaceutical production with a passion for continuous improvement (including Lean Six Sigma Qualifications) and a willingness to develop drug substance manufacturing knowledge (e.g. upstream and downstream manufacturing / Media prep).

Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care. Ipsen aim to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases. At Ipsen Wrexham, we focus on neurosciences and support ‘end to end’ Biopharmaceutical Development from Discovery, through Development, to Commercial Manufacture; a unique breadth within the UK.

**Main Duties & Responsibilities**

The API (LANT/BAS) Pharmaceutical Process Experts will be responsible for leading activities that support the technical transfer of LANT (new product) from BPD (R&D) into TechOps (Manufacturing). This will include transfer of Production activities, such as media and reagent preparation, upstream and downstream processing and activities that support the cleaning and maintenance of the Bioprocess Suite 2 (BPS2) facility.

Other duties include:

- Utilise prior experience in a GMP role to ensure full compliance of LANT manufacturing in BPS2 with cGMP and regulatory standards for drug substance manufacturing.
- Generate training packages (TRMs) in technical aspects of the LANT manufacturing process. These processes will be trained out by the individual to the BAS manufacturing team
- Critically evaluating each process step to identify, lead and drive improvements in all key strategic areas (Cost, quality, delivery, process) as part of the development phase, transfer phase and GMP manufacturing phase.
- Learn the ‘end to end’ LANT process and be able to support with developing the process in readiness for GMP transfer
- Lead problem solving initiatives for manufacturing investigations within LANT processes, ensuring meaningful Corrective/Preventative actions are assigned to drive improvement and alignment with GMP and regulatory standards.
- Participate in process development, monitoring and data gathering to drive analysis and improvements
- To lead and deliver Continuous Improvement activity in support of the objective to deliver a compliant GMP process
- Input/manage manufacturing data to support LANT process validation and continuous process validation
- Identify, liaise, and work with third parties to facilitate the tech transfer of LANT process

**Skills, Experience & Education**:
In return, you will bring:

- Experience in GMP pharmaceutical production
- Passion for continuous improvement (including Lean Six Sigma Qualifications)
- Willingness to develop drug substance manufacturing knowledge (e.g. upstream and downstream manufacturing / Media prep).


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