Shift Leader, Gmp Labs
5 months ago
We have a fantastic opportunity for an experienced Shift Leader. Leading continuous improvement, driving change & lead the GMP Laboratory shift team in their execution of high quality laboratory manufacturing to meet agreed objectives within agreed timelines.
Aptuit Oxford Limited is a drug development expertise and capabilities to pharmaceutical and biotechnology companies as well as to academic institutions. The company is a wholly owned subsidiary of Evotec SE.
Job Title Shift Leader (GMP Labs)
Job Type Permanent
Location Milton Park, Abingdon
Salary £45,000 plus excellent company benefits
- Performing GMP laboratory manufacturing projects in collaboration with other scientific staff to the required quality standard within a given timeframe following Aptuit safety regulations.
- Clearly and concisely record and communicate the results to the line manager/team members.
- The day-to-day planning of the activities of the GMP shift team, liaising with other project leads to ensure efficient use of resources. In addition, is responsible for long term planning and execution of projects within GMP manufacturing.
- Supervise and train as necessary shift Scientist, Scientist I and Senior Scientists and ensure that the correct procedures are being followed and the quality of work is to an appropriate standard.
- Leads the continuous improvement of the shift team and GMP Manufacturing processes through modernisation and training.
Role Description
- Demonstrates scientific proficiency, independent creativity and ability to collaborate with others in a team environment.
- Adheres to IOP/SOP's regarding accurate documentation of laboratory experiments.
- Complies fully with the company safety policy (including COPs and SOPs) in performing experiments.
- Understand and interpret the timelines and deliverables to ensure that a project is suitably planned and executed. Where the project timelines are impacted to have awareness that this is the case and communicate the challenges whilst there remains time to effect change.
- Provide direction and guidance to their teams by driving the problem-solving process to successful outcomes. Assist more junior team members in the planning and execution of their work.
- Is a technical expert in GMP manufacture.
- Responsible for the preparation and review of documentation required to enable efficient transfer of processes to a GMP laboratory.
- Presents results at internal and client facing project meetings and is able to translate those results into a forward-looking work plan.
- Works with their teams and line manager to highlight and overcome unexpected obstacles and direct changes in work scope as the company / client priorities change.
- Gathers, evaluates and critically analyses chemical data. Has clear understanding of impurity profiles, impurity purge point and factors, have awareness of potential PGI's where appropriate and understanding of specification setting for intermediates and API.
- Good awareness of the broader issues surrounding their projects.
- May be responsible for the management and professional development of any direct reports through objective setting, career development, training, coaching and performance reviews.
- Actively partakes in the professional development of GMP laboratory manufacturing team.
- Responsible for safe working practices of themselves and other team members.
- Maintains excellent records in accordance with ALCOA and ensures that team members accurately record all experimental work and carry out all duties in compliance with the current company procedures.
- Serves as in-house expert on specific equipment or techniques and acts as advisor in their area.
- To accept other responsibilities and duties reasonably delegated by the line manager.
Knowledge, Skills and Abilities
- Local expert in a laboratory environment. Possess an in-depth knowledge of organic and process chemistry, experience in a wide variety of chemistry and purification techniques as well as the use of all common analytical methods. Skilled in the use of online literature research tools.
- Proven expertise in GMP Laboratory manufacturing as evidenced through sustained high performance in a number of previous projects.
- Proven ability to solve problems on assigned projects and able to influence projects other than their own.
- Able to assess if a decision can affect the outcome of the project in terms of output, quality and schedule and as appropriate will seek advice/approval from the line manager.
- Excellent organisational and communication skills and demonstrates an ability to work collaboratively and effectively in multidisciplinary teams in a fast-paced, high-energy environment.
- Self-motivated, independent, enthusiastic, cooperative, reliable and strong work ethic.
- Works with a high level of accuracy and demonstrates attention to detail.
- Demonstrates good judgment and is able to effectively deal with challenging situations, multiple demands and chang
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