Manage projects in biomanufacturing operations
Overview
This standard identifies the competences you need to manage projects in biomanufacturing operations, 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 projects in biomanufacturing operations, 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 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. You will be expected to work to verbal/written instructions and standard operating procedures, and to report against your departmental goals set by senior management, taking personal responsibility for your own actions and for the quality and accuracy of the work that you carry out.
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 projects in biomanufacturing operations, 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 determine the scope of the project, and the processes required to achieve it
P4 develop a full project plan which accurately identifies the project aims and objectives
P5 develop project objectives, work plans and schedules that are realistic and achievable, and that will meet the overall project aims
P6 form the project team, comprising the correct mix of subject and technical experts to deliver the project
P7 determine and agree individual roles and responsibilities within the project team
P8 develop and manage a monitoring process to review the progress of the project, adjusting the project plan as required
P9 obtain authority and support for the release of the necessary resources to carry out the project
P10 conduct and manage the project in accordance with the plan, consulting with subject experts and specialists according to the needs of the project
P11 report project progress to relevant parties, at the agreed stages
P12 deal effectively with problems within your control and report any that cannot be solved
P13 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 biomanufacturing 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 the key principles for project management success
K14 the different project management methods that can be used, and how to select the methods appropriate to your own circumstances
K15 the information that should be included in project plans to allow the project progress to be monitored and measured (including aims and objectives of the project, timescales, quality, cost and delivery requirements, resource requirements)
K16 how to arrive at an estimate of timescales for the project, and the need to set milestones for achievements
K17 the tools and techniques available for project planning and monitoring (including spreadsheets, graphs, Gantt charts, critical path analysis)
K18 how to allocate specific tasks and responsibilities to the project team members, according to individual skills and abilities
K19 how to monitor and evaluate the project progress effectively
K20 how to prepare the plans (to include the structure, style, clarity and compliance with relevant standards)
K21 how to conduct a project meeting, and the importance of obtaining team members’ agreement to changes in plans
K22 how to monitor progress of the project in terms of delivery on time, to budget and within agreed levels of quality
K23 how to report project closure, completion and final status to management, teams and customers
K24 how to solve problems and overcome barriers/difficulties encountered during the life of the project
K25 with whom to liaise and from whom to obtain relevant and specific information, to support and assist you in running the project
Scope/range
1. develop project plans that identify all of the following:
1.1. the project aims and objectives
1.2. milestones and deliverables to be met
1.3. individual tasks within the project
1.4. any special requirements that must be met
1.5. quality, cost and delivery outcomes
1.6. estimate resources required (eg, people)
1.7. start time required for the project
1.8. completion date of the project
1.9. the full cost of the project
consult with appropriate people in order to secure the release of four of the following resources:
2.1 people who have the required skills and knowledge
2.2. the relevant documentation and information
2.3. raw materials and consumables
2.4. equipment (eg, bioreactor, centrifugation, filtration, autoclaving, lifting and handling equipment)
2.5. work space/work area
2.6. any outside support services
2.7. special/specific safety equipmentmonitor the progress of the project to ensure that all of the following are met:
3.1. project deliverables on time
3.2. project achieved within budget
3.3. level of quality that is acceptableproduce reports on project progress using two of the following:
4.1. spreadsheet
4.2. Gantt charts
4.3. critical path analysis
4.4. project schedule
4.5. event calendar
4.6. other (please specify)record details of the project work, and communicate the details to the appropriate people, using:
5.1. verbal report
Plus one method from the following:
5.2. written or typed report
5.3. specific company documentation
5.4. computer-based record
5.5. electronic mail