- This is a key role in the achievement of company business objectives for the company Development and Manufacturing facility.
- The Laboratory Services Manager is responsible for successfully running an operational QC laboratory within the facility in accordance with the overall facility goals.
- They will be responsible for ensuring efficient and compliant day-to-day operations as well as positioning the Laboratory Services group so as to be able to support broader organisational objectives and development project activities.
- Responsible for designing, implementing and maintaining the lab-specific documentation required for the Quality Management System (QMS).
- Plan and implement operational systems to conduct laboratory testing in such a fashion as to control and reduce testing lead times and cost and improve other key indicators (such as reliability, flexibility, quality).
- Execute testing and certification/ disposition required for artwork, component, raw material, finished product and stability testing to meet business goals.
- Transfer/validate in-house methods and verification of compendial methods to ensure overall project schedule timelines are met.
- Effectively manage contract testing labs; ensuring cost effective service as well as adherence to overall schedule.
- Maintaining a motivated, knowledgeable, agile and talent based laboratory team.
- Facilitate staff personnel career development to ensure staff engagement, aligned with overall corporate goals
- Representing Laboratory Services on global project teams contributing to overall project plans.
- Providing input to development projects such that they can be executed effectively and in a compliant fashion.
- Providing analytical support for company development projects as required.
- Assuring a safe and compliant work place.
- Organising the periodic calibration and qualification programme for laboratory equipment.
- Develop annual business plans and budgets for the Laboratory Services group to ensure adequate resourcing to meet ongoing business priorities
- Make strategic proposals for ways to develop the Laboratory Services group (in terms of personnel and equipment) to ensure it is optimally placed to offer solutions to the wider organisation.
- Conducting audits of 3rd party suppliers and service providers.
- Monitoring, evaluating and resolving issues related to day-to-day activities of operations in coordination with Quality and other site functions to assure performance to schedule.
- Organizing inputs across functions to develop defined work plans for process improvements for existing products or to investigate issues related to production deviations or OOS. Participate on cross functional teams for investigations and deviation support.
- Working with Development, Operations and other functions to ensure a smooth transfer of technologies and products from Development to commercial manufacturing.
- In close collaboration with broader team, advocating and implementing initiatives in support of a continuous improvement philosophy
- Management of controlled drugs within the laboratory (as required).
Required Knowledge, Skills, and Abilities
- Good knowledge of quality systems, FDA and EU regulations and ICH guidelines as they relate to Quality Control.
- A successful track record of achieving success in a management or supervisory role in a commercial QC group within a pharmaceutical company. Highly flexible, works well in a team and has necessary skills to organise, communicate, influence and lead.
- Extensive “Hands-on” bench experience with chemistry analytical techniques, particularly chromatography and spectroscopy techniques.
- Experience with method validation and method transfer and associated troubleshooting required.
- Experience with method development and/or biopharmaceutical methods desirable.
- Experience as software administrator within the laboratory desirable. Knowledge of data integrity as it relates to the laboratory.
- Experience with microbiological testing or working in a sterile manufacturing environment desirable.
- Experience of managing in a best practice operational excellence environment desired, preferably with implementation experience (e.g. lean or six sigma techniques).
- Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems.
- An ability to think strategically and be a ‘go-to’ expert across the business.
- Recognize areas for improvement, and use initiative to implement change programs in support of progress
- Ability to deliver objectives on time, every time, while meeting all compliance and cost targets
Required/Preferred Education and Licenses
- BSc/MSc in science discipline required
- Qualified Person experience or educational requirements desirable
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.