Provide leadership for a biomanufacturing team
Overview
This standard identifies the competences you need to provide leadership to members of your biomanufacturing team, in accordance with approved procedures. You are required to motivate and support them to achieve the
objectives of the team and their personal work objectives. 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 be required to present records and details of your biomanufacturing work to the appropriate people.
You will be required to plan the work of your team, and to set and agree individual objectives. You will help them solve technical problems, monitor their progress against the objectives you set, and provide feedback and guidance for
improvements in their performance.
Your responsibilities will require you to comply with organisational policy and procedures for the leadership activities undertaken, and to report any problems with the activities, materials or equipment 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 team building/leading procedures. You will have an understanding of the leadership skills used, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
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 set out and positively communicate the purpose and objectives of your biomanufacturing team
P4 involve team members in planning how your biomanufacturing team will achieve its objectives
P5 ensure that each member of your biomanufacturing team has personal work objectives and understands how achieving these will contribute to achievement of the team's objectives
P6 encourage and support your biomanufacturing team members to achieve their personal work objectives and those of the team, and provide recognition when objectives have been achieved
P7 steer your biomanufacturing team successfully through difficulties and challenges, including conflict within the team
P8 encourage and recognise creativity and innovation within your biomanufacturing team
P9 give your biomanufacturing team members support and advice when needed
P10 monitor activities and progress against objectives across your biomanufacturing team, and encourage responsibility in individuals for their own actions
P11 communicate the required information about the work of your biomanufacturing team to authorised people, in accordance with departmental and 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 principles of Good Manufacturing Practice (GMP) applied in the workplace
K4 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
K5 the manufactured product and batch process tracking and records system
K6 the types of handling and sorting system, and the procedures used for products undergoing processing in the manufacturing facilities
K7 the importance of correct identification, and any unique organisational or manufacturing numbers
K8 the organisational requirements for maintaining the security of the workplace
K9 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K10 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K11 different ways of communicating effectively with members of your team
K12 how to set objectives which are SMART (Specific, Measurable, Achievable, Realistic and Time-bound)
K13 how to plan the achievement of team objectives, and the importance of involving team members in this process
K14 the importance of, and being able to show team members how personal work objectives contribute to the achievement of team objectives
K15 how to allocate work objectives and delegate responsibility to individuals in your team
K16 how to select and successfully apply a limited range of different methods for motivating, supporting and encouraging team members, and for recognising their achievements
K17 difficulties and challenges that may arise (including conflict within the team), and ways of identifying and overcoming them
K18 the importance of encouraging others to take the lead, and ways in which this can be achieved
K19 the benefits of, and how to encourage and recognise creativity and innovation within a team
K20 who the biomanufacturing team members are, their purpose, objectives and plans for them
K21 the types of support and technical advice that your biomanufacturing team are likely to need, and how to provide these
Scope/range
1. carry out all of the following leadership activities:
1.1 identify and utilise the expertise and skills of individual team members
1.2 obtain and give the relevant information to achieve team goals and objectives
1.3 plan tasks and objectives for the team to accomplish set goals
1.4 represent the team at meetings and in communications with senior colleagues and customers
1.5 improve the knowledge, skills and attitude of the team
2. use three of the following types of protective clothing and equipment:
2.1 laboratory coat/overalls
2.2 gloves
2.3 head/hair covers
2.4 safety shoes/shoe covers
2.5 safety glasses/visors
2.6 other (please specify)
3. record and communicate to the appropriate people, using all of the following:
3.1 verbal report
3.2 company documentation
3.3 electronic mail
3.4 written or typed report
3.5 computer-based record
3.6 graphs/charts