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  • Job reference: RMS0169879

Senior Analyst

  • Sector: Engineering
  • Location: Billingham
  • Job type: Contract
  • Date posted: 22/07/2016
  • Time left:
    d h m s
    (12/08/16)
This vacancy has now expired.
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
A Senior Analyst provides analytical support to Biologics manufacturing and ASG projects. The job holder is responsible for driving their own workload and that of the team they work within to ensure compliance with the technical, operational, SHE and cGMP of the work to generate high quality, relevant, accurate and timely data to support the production, characterization and allied studies on products. The jobholder will be expected to compile reports, identify anomalies with data and proactively contribute to the team objectives. The job holder will be expected to be able to organize work, influence team members, cross functional team members and to proactively support audits concerning the departments data and processes. Advanced knowledge in a range of microbiological, analytical and wet chemistry techniques. Demonstrated ability to quickly acquire new techniques. Subject Matter Expert in at least 3 Analytical Techniques.

GMP RESPONSIBILITIES

1. To ensure all laboratory work undertaken is performed in accordance with cGMP quality system. The consequences of getting this wrong can range from the loss of data to support the use of material in clinical trials, to the loss of marketed batch of material. This could lead to lengthy delays for client programs and potentially to loss of business and company reputation.
2. Identify concerns with processes, methods or data and where possible develop or contribute to the development of solutions with management support.
3. Identify, raise and offer solutions under supervision for aspects of the quality system and opportunity for continuous improvement within own and team areas.
4. Actively contribute to and drive scientific and quality investigations concerning analytical studies, data, OOS, OOT, etc.
5. Responsible for ensuring that team quality metrics are always in control.

EHS RESPONSIBILITIES
1. To ensure that all work undertaken complies with safety assessments contained with analytical methods and risk assessments.
2. To draft and gain management and EHS approval for key risk assessments for activities in laboratories.


PRINCIPAL ACCOUNTABILITIES
1. To work with management and act as a motivational team player.
2. To help form and then deliver plans & objectives set for the team.
3. To have own work plan over period 1-90 days.
4. To work with management to ensure team plans are in place over 3 month period.
5. To generate data following applicable quality systems and local procedures to ensure accurate, well recorded, high quality data.
6. Peer review of other data as part of the data checking processes.
7. Support Study Owner to compile reports, investigation data, etc. and to begin to develop experimental approach to solve issues with management support.
8. To identify and raise concerns with management re: data anomalies or opportunity for continuous improvement.
9. Own, drive and take to conclusion detailed laboratory investigations.
10. Maintenance of key lab systems (eg: KanBan, 5S, etc.).
11. Good communication and influencing skills demonstrated within team.
12. Cross functional working (AD, QC, QA, etc.) – seen as key player in studies.
13. Work with management to ensure that quality items are always in control within team.
14. Work as a mentor to help develop theoretical and practical skills of other team members.
15. Self-starting demonstrated ability to research and acquire new techniques rapidly.
16. Flexibility to adapt to changing plans.
17. To train/offer guidance to colleagues and to give formal mentorship in general principles of work and techniques that they are competent in.
18. Tier meeting representation when required.
19. Deputise for Study Owner if required

Essential Skills / Qualifications:
1. Must have the willingness to seek out knowledge, assimilate training and to develop their competence rapidly in new techniques.
2. Must possess the ability clearly communicate within their team, with external auditors and clients in a professional manner.
3. Expected to work across functions (AD, QC, QA, etc.) and work within a multidisciplinary environment and when necessary present data to clients.
4. Must have the ability to generate data following local procedures and Quality process to assure the data.
5. Must be able to critique data/reports/processes and identify concerns and suggest ways in which issues can be rectified.
6. Must be graduate or PhD level scientist with relevant experience.
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