An amazing opportunity for an experienced immunoassay scientist to join the manufacturing team at an innovative and vibrant biotechnology company. This company combines amazing work with an amazing culture - where you will assist with the design and delivery of cutting edge and outstanding new healthcare solutions to market, with an unbeatable team. The role represents the prefect opportunity for a GMP experienced Scientist to make extensive use of their skills while building a career with a company that values and fosters their talent. If this role sounds like it could be the perfect fit for you, or you would like to know more, then get in touch! We would love to hear from you. An excellent salary and benefits package are on offer to the successful candidate, in addition to other amazing perks and bonuses.
This role is full-time/permanent and will be based in Stirling. The role will be working shifts 24/7 shifts (4 on 4 off) with a lucrative shift allowance.
You will work within a team of technicians and scientists in a GMP environment to facilitate the validation and transfer of new process and test methods from development into the manufacturing department. You will also provide support where required to manufacture and test reagents for commercial sale and related validation activities. You will be part of the manufacturing team but will also be required to work in collaboration with the development transfer team, acting as trainer for the new processes to be implemented. You will be responsible for Reagent Manufacturing Technicians and will report into the Reagent Manufacturing Team Leader.
You will be responsible for validation of new assays into the manufacturing department that achieve the consistently high quality required for progression to Production and that meet the Design for Manufacture requirements. Responsible for performing ongoing process improvement activities for existing assays. You will have people management and development responsibilities.
- Provide feedback and evaluation support to R&D to aid delivery of suitably robust processes and test methods.
- Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of reagents.
- Ensure raw material and consumable availability for new processes, creating documentation where required and communicating with Supply Chain
- Support the design, execution and analysis of experiments for improving reagent manufacturing operations.
- Work in collaboration with transfer team to introduce new processes to manufacturing and roll out effective training.
- Prepare process buffers and stock solutions to allow reagent manufacturing and validation schedule to be met.
- Manufacture assay reagents safely, efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
- Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
- Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Responsible for upload of real time material and labour data into ERP system.
- Adhere to all relevant regulatory GLP, GMP and GDP requirements.
- Lead in the creation and update of SOPs, WIs and validation protocols as required and coordinate appropriate technical review
- Ensure creation and update of COSHH assessments, acting as technical review, and follow and comply with all relevant internal quality and H&S processes and procedures.
- Raise Non-conformances, lead investigations and corrective actions and support other team members.
- Accurately complete batch records and reports, recording and communicating all process observations and deviations.
- Technically review process documentation, lab books and reports, and provide feedback to team members to support a Right First-Time culture.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and people development, along with the following experience:
- Degree level qualified, or equivalent, in a science subject.
- Experience working within a manufacturing laboratory following good lab practices and confidence to work without supervision.
- Ability to create and follow complex protocols and accurately complete batch records.
- Good at problem solving and troubleshooting.
- Computer literacy, data analysis interpretation skills and good attention to detail.
- Good communication, personal task management skills and high self-motivation.
- Can work well within a group environment.
- Knowledge of in-process testing such as electrochemical, fluorescent and particle analysis methods (e.g. Flow Cytometry, Dynamic Light Scattering).
- Knowledge of GMP standards, including Validation protocols and Non-Conformances.
- Experience of working within a biohazard environment.
- Commercial diagnostic assay experience.
- Experience in statistical analysis techniques.
- Six Sigma Green Belt or Black Belt Qualification.
- Line management experience.
Apply online in the first instance, or contact Liam Baxter at Tel: 0141 270 5136 or email your CV to lbaxter@FPSG.com
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.
We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process