Drug Substance Testing Team Leader
Date: Feb 14, 2018
Location: Braine L'alleud, BE
NATURE & SCOPE
- Release, Stability, project support analytical testing and double check for Drug Substance (DS) related activities.
- Physical-chemical analytical activities supporting New Chemical Entities (NCE).
1. Manage the technician team encompassing DS NCE projects.
2. The function will consist in managing the technician team to ensure optimal phys-chem analyses and doublecheck on due time.
3. This function will be the QC representative for DS products.
4. The function will build strong analytical knowledge for Phase III and commercial chemical products.
5. The function will participate to the implementation and follow-up of new lab process flows.
6. The function includes the management of regulatory aspect linked to activities, ensure the interface between the NCE lab and Regulatory Affairs, and insure NCE testing lab being compliant to regulation requirement updates.
1. Motivate, recognise team members performance, maintain discipline and compliance of rules whilst firmly supporting team work and spirit. Manage conflicts.
2. Increase team's competency by ensuring adequate training, coaching and development of technicians in function of the team and people potentials.
3. Define and communicate openly the objectives of individuals and of the team in accordance with the company's strategy and formally assess the results with the adequate KPI (Key Performance Indicators) covering HSE, quality and overall performance both for the individuals and the team.
4. Ensure interim review and end year performance review of each team member as well as their contribution to the team in time in full.
5. Ensure job descriptions & training plan of people are in lign with the QC organisation.
6. Be back-up of the RM TL, DP TL or NCE head when needed.
1. Ensure the day-to-day operational planning and coordination in order to satisfy the client needs based on a montly forecast.
2. Organise daily meetings with team to follow-up on the planning and collect and give informations. Ensure that each one contribution is done in due time.
3. Ensure required corrective actions are taken and put in force.
4. Implement, follow-up and communicate on KPI with its related corrective actions.
5. Inform customers and/or NCE head if deviations from the day-to-day-planning occur.
6. Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
7. Ensure that continuous improvement is part of day-to-day activities of the laboratory.
8. Ensure the lab infrastructure is maintained.
9. Maximize the utilisation of departements budget within given budget limits.
10.Be accountable for a pro-active collaboration with Pharmaceutical and Packaging Plants, QA/RA (validation), Metrology (calibration), BPS, HSE (Security and Environment), HR (Human Resources), CoE (Centers of expertise).
1. Ensure update of procedures and instructions.
2. Ensure follow-up of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits.
3. Ensure the follow-up of OOS and take actions to reduce the number of laboratories OOS.
5. Ensure adequate training/coaching of technicians linked to the analytical activities requested and performed.
1. Ensure a safe working environment to meet site safety objectives.
JOB PROFILE (education & experience necessary for this position)
Bachelor / Master +5yrs in a GMP lab, 3+ years of management experience
Experience in commercial areas of the pharmaceutical industry required (NCE).
Must have experience in a GMP regulated laboratory.
Specific skills :
1. A very good management background is imperative. Capacity to cope with change management, high sense of empathy, capacity to motivate and make people grow through proper training and delegations.
2. Ability to evaluate staffing and means versus project workload and translate into a clear action plan with an appropriates follow-up is essential. Must be able to manage multiple projects at the same time.
3. Operational excellence and compliance should be the 'must' reference of any operational decisions.
4. Capable to make one's proper decisions by utilizing strong analytical skills, troubleshooting and problem solving approach.
5. Masterise interpersonal, verbal and written communication skills.
6. Key technical backgrounds: HPLC / UPLC, GC, dissolution, CHN, atomic absorption, pharmacopea testing, particule size, IR, spectroscopy, potentiometry, ICP-MS.
Problem solving (describe the level of "self-starting" thinking required in the for recognizing, analyzing and solving problems):
- Scientific Problem solving:
- Good level of analytical troubleshooting needed for support to Manufacturing and laboratory issues (including outsourcing lab).
BPS, NCE Manufacturing, Process optimization, QA, RA, HR, Technical Leaders, API and DP CoE
1. FDA, European and Japanese investigators and reviewing scientists, USP, EP delegates and pharmaceutical industry interest groups.
2. Materials suppliers.
4. Interact with CRO/CMO for outsourced projects.
UCB offers a permanent contract
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