Kedrion Biopharma is recruiting for a skilled Technical Specialist with experience in chromatography to join their Technology Department at the Elstree site.
The role involves focusing on Mission Ownership objectives, including enhancing batch throughput, product yield, and process quality. Responsibilities also include aiding in technical transfers, new product introductions, and supporting deviation investigations. The Technical Specialist will excel in fault finding, data analysis, and process performance monitoring through statistical process control methods and be able to participate and potentially lead in Root Cause Analysis (RCA) and the generation of Risk Assessments.
As part of the technical transfer process, the Technical Specialist may also be required to assist in the development, commissioning, and introduction of new products and processes from R&D into manufacturing areas.
Kedrion Biopharma is a biopharmaceutical company headquartered in Italy, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.
Duties & Responsibilities will include –
- Complete tasks as assigned to support delivery of Technology Mission Ownership Objectives
- May be involved with introduction of new equipment, products and processes into production areas.
- May write or update controlled documents including SOPs and Process Instructions and where appropriate develop training material to support transfer of projects into manufacturing
- Become a technical subject matter expert (SME) for processes/projects within your scope of responsibility
- Assist in quality investigations, either by direct ownership or coordinating the resolution of specific quality records and be responsible for their on-time closure
- Actively participate in or take the lead in the development and implementation of continuous improvement initiatives to help ensure BPL meets its yield, capacity and quality performance targets.
- Build relationships with colleagues across Technology, Operations, Quality and R&D to enable smooth of project goals and objectives
- As a minimum has a basic skill set for the collection, analysis and interpretation of process data and information and may have some capability for carrying out statistical analysis
- Be familiar with and able to apply the basic tools of Operational Excellence for continuous improvement and problem-solving activities.
- Already be or able to work towards Operational Excellence accreditation as a white or yellow belt
- Write and or manage change controls or tasks assigned to them to ensure changes to processes are compliant and delivered on time in full.
- Participate in or lead quality risk assessments as appropriate to prepare for and consider the impact of any change proposals to manufacturing processes.
- Trend key process parameters using recognised methodologies, such as SPC, analyse data, test hypotheses and form conclusions and or recommendations from that analysis
- Contribute to the development of tasks and sub tasks related to the delivery of Mission Ownership Objectives
- Health & Safety - Follow the BPL Health & Safety policy and guidelines. Bring any risks or issue to the attention of your manager or the EHS department. Focus on improving Health and Safety at all times.
- Policies - may contribute to the development or revision of BPL policies relevant to their area of expertise
Skills & experience to help you within the role –
- Degree or equivalent in science or engineering based subject or experience of pharmaceutical or other technical manufacturing.
- Experience of protein purification techniques e.g. chromatography Industrial scale experience of protein purification
- Understanding of GMP manufacturing
- Worked in GMP role in the pharmaceutical industry
- Root Cause Analysis (RCA)
- Delivered changes to processes
- Experience of formal change management
- Continuous Improvement methodology
- Working knowledge of risk assessments
- Written SOPs
- Experience of delivering training
- Delivered capital projects as part of a team
- Logical and systematic approach to problem solving
- Able to communicate ideas to colleagues of all levels
- Willing to be hands on in production area supporting manufacturing Computer literate, proficiency with Excel useful
- Able to analyse data, test hypotheses and form conclusions
- Motivated to make improvements and demonstrate drive for results completion
- Continuous Improvement methodology
We're looking for highly motivated and experienced people to drive the business forward. If you are passionate about process improvement and analysing data then we want to hear from you.
In return we offer -
- 25 days holiday (plus bank holidays)
- Employee assistance programme
- Employee discounts and cash back
- Employee recognition programme
In 2022, Kedrion joined forces with BPL (Bio Products Laboratory). Based in Elstree, BPL operates a targeted portfolio of successful plasma-derived products to treat rare diseases. There are nearly 1000 colleagues based at the campus, where a number of our life-enhancing plasma-derived products are manufactured.
With the combination of Kedrion and BPL, the company now becomes a global player in plasma derivatives and rare disease medicines employing more than 4,800 people worldwide. As a joint company, we function as a bridge between donors and the people who need treatment, and work on a global scale to expand patient access to plasma-derived therapies.
Please apply today for immediate consideration.
