Manage budgets for biomanufacturing projects
Overview
This standard identifies the competences you need to manage biomanufacturing project budgets, in accordance with approved procedures and practices. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will also be required to present records and details of your biomanufacturing work to the appropriate people.
Your responsibilities will require you to comply with organisational policy and procedures for managing project budgets for biomanufacturing activities, and to report any problems that you cannot personally resolve to the relevant authority.
Your underpinning knowledge will provide a good understanding of general and discipline-specific biomanufacturing development principles and processes, and you will also be fully conversant with organisational procedures and systems. You will be required to report any problems with the biomanufacturing activities that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to managing budgets for biomanufacturing projects, in accordance with approved procedures and practices. You will have an understanding of the manufacturing methods and principles used, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect yourself and others in the workplace.
This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.
Performance criteria
You must be able to:
P1 ensure that your work is carried out in accordance with standard operating procedures
P2 wear the appropriate personal protection equipment (PPE) when working in the biomanufacturing environment
P3 evaluate available information and consult with others to prepare a realistic budget for the respective area or activity of work
P4 submit the proposed budget to the relevant people in the organisation for approval and to assist the overall financial planning process
P5 discuss and, if appropriate, negotiate the proposed budget with the relevant people in the organisation and agree the final budget
P6 use the agreed budget to monitor and control performance for the respective area or activity of work
P7 identify the causes of any significant variances between what was budgeted and what actually happened, and take prompt corrective action, obtaining agreement from the relevant people if required
P8 propose revisions to the budget, if necessary, in response to variances and/or significant or unforeseen developments, and discuss and agree the revisions with the relevant people in the organisation
P9 provide ongoing information, on performance against the budget, to relevant people in your organisation
P10 advise the relevant people as soon as possible if you have identified evidence of potentially fraudulent activities
P11 gather information from implementation of the budget to assist in the preparation of future budgets
P12 communicate the required information about the work done, to senior management and other authorised people, in accordance with organisational procedures
Knowledge and Understanding
You need to know and understand:
K1 the health and safety requirements of the area in which you are carrying out the biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting bioanufacturing activities
K3 the standard operating procedures, as set down in local biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operating instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and process them
K7 the manufactured product and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for products undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K13 your organisation’s requirements for recording and archiving reports, and the use of a unique identify code
K14 the purposes of budgetary systems
K15 where to get and how to evaluate the available information in order to be able to prepare a realistic budget
K16 the importance of spending time and consulting with others in preparing a budget
K17 how to discuss, negotiate and confirm a budget with people who control the finances, and the key factors that should be covered
K18 how to use a budget to monitor and control performance for a defined area or activity of work
K19 the main causes of variances, and how to identify them
K20 the different types of corrective action which could be taken to address identified variances
K21 how unforeseen developments can affect a budget, and how to deal with them
K22 the importance of agreeing revisions to the budget and communicating the changes
K23 the importance of providing regular information, on performance against the budget, to other people
K24 types of fraudulent activity, and how to identify them
K25 the importance of using the implementation of the budget to identify information and lessons for the preparation of future budgets
Scope/range
1. manage budgets for all of the following activities:
1.1. accrued vs. actual project expenditure
1.2. project cashflow
1.3. project team costs
1.4. project equipment costs
1.5. project resource costs
1.6. other (please specify)
agree budgets with two of the following:
2.1. colleagues in your own working group
2.2. supervisors/managers
2.3. more senior professionals/scientists
2.4. colleagues outside your normal working group
2.5. persons external to your organisationrecord details of the project work, and communicate the details to the appropriate people, using:
3.1. verbal report
Plus one method from the following:
3.2. written or typed report
3.3. specific company documentation
3.4. computer-based record
3.5. electronic mail