QC In Process Team Lead
In this role, you will be responsible for the following:
- Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration;
- Support the development of a Biologics QC In Process testing shift team including planning, recruiting/hiring, coaching/mentoring, and training;
- Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations;
- Communicate, collaborate, and cooperate with MFG and QC functional teams and other departments to support site operations;
- Manage In-process team shift rota;
- Team Lead and line Manager for QC In Process Scientist and Associate Scientists, providing guidance and direction, performance management, training plan through scheduling, and direct 1-2-1 with the team;
- Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs;
- Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings;
- Seek opportunities for continuous process improvements/improved operational excellence;
- Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner;
- Support Risk Assessments for projects and business innovation initiatives;
- Ability to work in a team environment and independently as required;
- Aligned with the project timelines managing and leading a team will also be required as part of the role;
- Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.;
- Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Associate Director;
- Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.
The ideal candidate for this position, will have the following:
- Experience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal;
- Previous experience handling regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance is advantageous;
- Experience working in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field is desirable;
- Technical expertise in tech transfer, validation, and troubleshooting Biologics in-process forward processing test methods, including HPLC Titer Determination and UV Protein Concentration to support in a GMP-environment according to USP, EP, and ChP requirements is preferred.
- More than 8 years’ experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential;
- Previous experience managing and leading a small team would be advantageous;
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required;
- Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required;
- Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable;
- Previous experience working in a CMO is an advantage;
- Previous experience of shift work/managing a shift team is an advantage.
- Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
- University degree in related science/quality discipline required.
- Strong leadership competencies with demonstrated management skills;
- Excellent interpersonal, verbal, and written communication skills;
- Able to think critically and demonstrate troubleshooting and problem-solving skills;
- Self-starter and self-motivated; organized with good attention to detail;
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities;
- Results oriented, with the ability to manage multiple priorities in a short period of time;
- Collaborative and inclusive approach to work and your colleagues.
Don't forget to mention EuroPharmaJobs when applying.