- Effectively coordinating and managing team members so that productivity, quality, documentation, work schedules, safety and housekeeping is run at maximum efficiency.
- Responsible for ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
- Responsible for the development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
- Responsible for reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
- Responsible for ensuring that work is scheduled, and cross training takes place so that the service levels agreed with the customer are achieved. Responsible for amending schedules as required.
- Ensure that all analysts are trained and have completed training records for all activities and other training completed.
- Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
- Responsible for continuous feedback to all members of their team on all items in relation to client or organisational requirements / changes.
- Responsible for handling any customer related queries where necessary and liaising with their team and with personnel from other teams to problem solve these queries if needed.
- Perform investigations, where required, for API Large Molecule Lab issues etc.
- Perform other duties as designated by Laboratory Management.
- Support early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
- Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
- Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations. Partner with Project Teams to provide input, review and approval support for BLA submissions.
- To interpret project plans and timelines for CMC projects and schedule work and experiments to meet these goals.
- To assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
- To execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
- To foster a culture of Lean and Continuous improvement within the department and with internal and external partners.
- A Bachelors’ Degree or Masters’ Qualification or PhD Qualification in Biotechnology, Biopharmaceutical sciences or relevant biological or life science is required.
- At least 5 years of GMP industry experience
- Excellent leadership skills and at least 3 years’ previous supervisory experience.
- Analytical skills to troubleshoot laboratory issues are an asset.
- Ability to quickly learn new processes.
- Experience in aseptic techniques is required.
- Ability to communicate clearly and to form strong working relationships with colleagues.
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Organised, accurate, have strong documentation skills.
- Passionate about quality and customer service.
- Good communication skills both internally and externally.
- Excellent attention to detail
- Good communicator – easily communicate findings and recommendations to internal clients.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4809118 or email firstname.lastname@example.org