As part of Bio Products Laboratory’s (BPL) future plans to grow and solidify BPL’s presence as a leading provider of Plasma derived Medicinal Products for patients and customers, we have an exciting new opening for a Technical Specialist to play a key role in delivering improvement projects aiming to increase capacity and / or product yield of our production processes at our site in Elstree, Herts.
The Technical Specialist will become an expert in one or more of BPL manufacturing processes and be able to demonstrate competency in fault finding, data capture and analysis and also trending of process performance using statistical process control.
This role is ideal for someone with a process development background working on improvements to increase batch throughput, product yield or to reduce process variation and assure or improve product quality.
This really is a wonderful hands-on opportunity for someone interested in working with a reputable Pharmaceutical Manufacturing environment who would also enjoy the change to assist in the development, commissioning and introduction of new products and processes from R&D into manufacturing areas.
Key duties & responsibilities –
- 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
- 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
Experience and attributes to make you successful in the role –
The following are essential:
- Degree in Biotechnology, Chemistry, Biology or similar
- Delivered changes to processes
- Continuous Improvement methodology
- 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
The following are desirable:
- Continuous Improvement qualification
- Project management qualification
- Working knowledge of risk assessments
- Written SOPs
- Experience of delivering training
- Delivered capital projects as part of a team
- 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
Our salary and benefits include –
- Competitive salary, bonus and benefits
- 25 days holiday
- Life insurance
- On-site free parking, with a subsidised restaurant
Bio Products Laboratory (BPL) is a niche pharmaceutical business located in Elstree, Herts.
Our products change people’s lives, and the purpose of our work is lived and breathed through its people. Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.
To start your career with BPL, please apply today.