Senior Analyst Job Description Job Title Job Holder Reports To Location Date Grade Job Purpose A Senior Analyst (manager) 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 organise their own work, as well as that of others in the team, influence team members, cross functional team members and to proactively support audits concerning the departments data and processes. The job holder will line manage junior members of the team. Dimensions 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. Senior Analyst (Manager) Vacant Study Owner Billingham 13Sep17 32 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. Accountable for safe practices of working and for escalating any issues related to safe working practices 3. To draft and gain management and EHS approval for key risk assessments for activities in laboratories. Turnover £100 million Site Numbers 500 No of staff reporting to individual 1 Forward work plan 90 days Analytical knowledge 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.
Number of programmes 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 a key player in studies. 13. Work with management to ensure that quality items are always in control within team. 14. Self-starting demonstrated ability to research and acquire new techniques rapidly. 15. Flexibility to adapt to changing plans. 16. Tier meeting representation when required. 17. Deputise for Study Owner if required. Competencies Competency Demonstrated Behaviours Concern for Standards Sets high personal standards as an example Takes firm action on sub-standard performance Explicitly defines consequences of not achieving standards Works to meet standards of excellence Takes action to ensure consistent application of procedures/systems Makes sure that work is completed in an accurate and timely fashion Makes sure that work meets quality standards Results Orientated Sets specific goals for self Communicates clearly and concretely the results to be achieved Keeps own and others’ activities focused on key objectives Determines whether results have been achieved Keeps people informed about what needs to be done in the light of changes in the organisation Takes appropriate action to achieve objectives Eliminates unnecessary risks Acts to avoid unnecessary distractions from key objectives Applies experience and expertise to achieve objectives Ability to Learn Quickly understands what new tasks/jobs are required Easily learns unique job-related vocabulary Quickly understands and uses processes, technologies and ideas that are continually being updated Easily learns new information regarding changing products, operations etc. Understands and learns to work with new business, office and information technologies Learns highly complex information regarding a product of operation Is open to and understands new ideas Interpersonal Awareness Draws inferences about others’ concerns and interests Understands the unspoken meaning in a situation Senses others’ emotional states and ways of thinking Is sensitive to changes in other people’s moods or temperament Detects the concerns, interests or emotions which seem to lie behind what people say Is aware of the feelings of others Thoroughness Follows up incomplete or inadequate answers to pin down the facts Acts to reconcile inconsistent forms of data Support to 5-15 at one time Sees things from others’ viewpoints
Takes action to tie up loose ends Checks to ensure data is accurate and sustainable Makes sure all necessary tasks have been completed Checks work for errors and omissions Takes care of both small and large aspects of a task Keeps track of many details without forgetting items Modifies a strongly held opinion in response to contrary evidence Modifies own behaviours in response to a situation Works around obstacles that prevent completion of projects Sees the merits of differing positions of opposing viewpoints and changes behaviour accordingly Adjusts behaviour to suit new procedures and systems Modifies behaviour in order to reach a goal Maintains effectiveness during rapidly changing assignments or priorities Changes plans if circumstances dictate Remains calm when personally attacked Keeps things in perspective, despite fatigue or frustration Maintains effectiveness and commitment in the face of disappointment Copes effectively with ambiguity Is objective under pressure and in difficult or stressful circumstances Works effectively under tight deadlines Maintains business-like approach when unduly annoyed, disturbed or disrupted by others Maintains objectivity when interpreting information and defining problems Develops and uses clear criteria for guiding decisions Identifies cause and effect relationships Thinks through the consequences of different courses of action Considers pros and cons before decided Identifies root cause, Thinks through priorities Understands and evaluates numerical data, tables, charts, or graphs to get to the cause of a problem Performs calculations and combines quantitative information in order to diagnose and solve a problem Develops a list of decision making guidelines to help arrive at logical solutions Makes sense of information by organising it Seeks critical data to test a hypothesis Carefully structures questions to find out more about a problem Gathers key information to diagnose a problem Probes for sensitive strategic information Identifies the most appropriate people possessing information relevant to a problem Gets important information that others would not get Gathers information from key sources in attempting to understand fully the cause of the problem Talks to key people to gather information needed to make decisions or recommendations Searches records or files for critical information Gathers information from all key stake holders in a problem or task Sticks with the problem until it is resolved Repeatedly pushes others to do something Demonstrates unflagging energy in pursuing a problem Works unusual hours to accomplish a goal Keeps trying to complete a goal despite encouraging obstacles Demonstrates repeated efforts to complete a task Stays with a position or plan or action until the desired objective is achieved or no longer reasonably attainable Flexibility Self-Control Analytical Thinking Critical Information Seeking Tenacity
Desirable Competencies Competency Self-development Demonstrated Behaviours Explores personal strengths and weaknesses with a view to improve Critiques own performance as a means of self-improvement Seeks opportunities to build knowledge in work related areas Seeks opportunities to build knowledge in areas seen to be useful but extending beyond immediate areas of work Actively seeks feedback as a significant source of learning and improvement Plans activities to improve personal capability at work Asks for suggestions and new ideas for self-improvement Learns from mistakes Seeks developmental projects and tasks Seeks training programmes to develop new skills Continually ‘scans’ and applies developments in fields that are important to oneself Draws on reason and logic in making a case Uses cost benefit arguments in order to influence Presents arguments based on factual information Demonstrates that a course of action is of mutual interest Points out how a course of action is/is not effectively related to the expressed interests of the other party Relates suggested solutions to the needs of the listener Refers others to source data when debating contentious issues Focuses on the problem rather than the person in a debate Rational Persuasion
Special Features– 1. The jobholder must have the willingness to seek out knowledge, assimilate training and to develop their competence rapidly in new technique. 2. The jobholder must possess the ability to clearly communicate within their team, with external auditors and clients in a professional manner. 3. The job holder must have the ability to generate data following local procedures and Quality process to assure the data. 4. The jobholder must be able to critique data/reports/processes and identify concerns and suggest ways in which issues can be rectified. 5. The jobholder will be a graduate or PhD level scientist and have a minimum of 4 years of relevant experience. Organisation Chart Stability Group Manager Stability Study Owner Head of ASG Senior Analyst Signatures Job Holder: Manager: . . . . . . . . . . . . . . . . . . . . . . . . . Date: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date: . . . . . . . . . . . . . . . . .