An amazing opportunity for an experienced Analytical 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 Analytical 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.
You will work within a shift team of technicians and scientists in a GxP environment to test raw materials and manufactured reagents for commercial sale and use in related validation activities. This role is full-time/permanent and will be based in either Stirling. The role will be working shifts 24/7 shifts (4 on 4 off) with a lucrative shift allowance.
You will be responsible for performing analytical test methods as required for all reagent manufacturing materials (raw/in-process and final formulations) to assess their quality, performance and impact on final product performance and ensure delivery of consistently high-quality assay reagents to production. Responsible for investigation and improvements on existing test processes and supporting routine manufacture of reagents where required. Will execute validation activities for introduction of new analytical test methods and support ongoing monitoring of data produced.
- Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing to support manufacturing activities, work to established test specifications.
- Prepare process buffers and stock solutions to allow reagent manufacturing, testing and validation schedule to be met.
- Support preparation and manufacture of assay reagents safely, efficiently and in line with schedule and SOPs/WIs to meet strip production requirements.
- Carry out routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of all reagents.
- Ensure raw material and consumable availability for new test methods, creating documentation where required and communicating with Supply Chain
- Execute validation and ongoing monitoring of analytical test methods and equipment.
- Support development and transfer of new analytical test methods for raw materials, intermediates and final manufactured assay reagents.
- Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Adhere to all relevant regulatory GxP requirements.
- Lead in the creation and update of SOPs/WIs as required
- 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 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, along with the following experience:
- Degree level qualified, or equivalent, in a science subject including Analytical Chemistry.
- Experience and strong knowledge of HPLC/UPLC, FCM, DLS, Rheology, MS, UV/Visible spectrophotometry, and related wet chemistry techniques.
- 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 GMP standards, including Validation protocols and Non-Conformances.
- Ability to work 12 hour shifts to support 24/7 manufacture.
- Experience of working within a biohazard environment.
- Commercial diagnostic assay experience.
- Experience in statistical analysis techniques.
- Six Sigma Green Belt or Black Belt Qualification.
- Knowledge of Nanoparticles and Antibody Conjugates.
Apply online in the first instance, or contact Liam Baxter at Tel: 0141 270 5136 or email your CV to lbaxter@FPSG.com
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