Descriptif de la mission
Leadership responsibilities
- Lead a team in a matrix environment,
- Maintain staff by recruiting, selecting, orienting employees,
- Define the annual objectives of his/her group in alignment with the objectives of Pharmaceutical
Development & R&D. Lead his/her team by mobilizing it around its objectives and evaluates the
outcomes,
- Provide effective and continuous feedback, through employee recognition, rewards, performance
appraisal and development discussions,
- Define and propose the training/development plan for his/her team, ensure its implementation and
carry out the follow-up. Develop, monitor and guide the levels of expertise of his/her team in terms of
knowledge and know-how. Ensure continuous professional development of its employees,
- Anticipate any resource needs to ensure that his / her team provides deliverables in time, with the
expected quality.
Clinical packaging responsibilities
- For each asset and each clinical study, define the clinical packaging strategy and ensure alignment with
clinical needs and internal capabilities,
- Define clinical packaging plans (short, mid and long term) for the client assets (small molecules and toxins)
according to clinical forecasts and timelines to ensure on-time in full supply to patients,
- Anticipate and assess the impact of changes in clinical studies (study design, development plans) on the
packaging plans,
- Perform prioritization exercise when needed,
- Act as a key interface with the Global Clinical Supply Management, Clinical Manufacturing, Quality
Assurance and Analytical Development teams,
- Represent his/her function in cross-functional project meetings to support clinical study launch,
- Perform the make vs buy assessment for the secondary packaging and labeling activities,
- Participate to the implementation of packaging activities at CDMOs: contracts and Quality Technical
Agreements implementation, first batch records review.
- Coordinate and lead internal meetings involving relevant functions for packaging campaign preparation
and follow-up,
- Ensure semi-finished products needs for packaging campaigns are aligned with manufacturing plans
from the clinical manufacturing team,
- Identify packaging articles in line with clinical requirements and run mock batches to assess kit design
feasibility before formal implementation,
- Develop/maintain a network of efficient qualified suppliers to ensure his / her activities,
- g master
data management, incoming goods order, receipt and release as well as batches set up in the ERP
system,
- Ensure robust stock management process are in place,
- Ensure the on-time availability of the documents and materials including semi-finished products and
packaging materials required for his/her activities,
- In collaboration with the Operational Quality Assurance team, ensure the review of the manufacturing
batch records and support quality events management in line with defined KPIs,
- Ensure Ready to Dispatch deliverables are met and communicate frequently with the Distribution team, - Ensure the follow-up of the quality management system related to its perimeter (KPIs, risk analysis, self-
evaluation, internal audit, etc.) in close collaboration with the Quality Department,
- Be the contact person for his perimeter during visits, audits or regulatory inspections,
- Ensure technical and regulatory surveillance related to his / her scope (guidelines, GMP, Annex 13 ),
- Guarantee adequate communication and alignment within the Drug Product Development department,
the CMC workstreams and more broadly within Pharm Dev.
- Follow and communicate on team performance through relevant KPI, - Manage packaging areas and define appropriate CAPEX plans
Critères requis
Education / Certifications :
Pharmacist, engineer, degree in science or equivalent
Experience:
7-10 experience in the pharmaceutical industry with a focus on Manufacturing activities
Languages:
Fluent in English to effectively interface with English-speaking subcontractors
Technical skills :
Strong experience and knowledge on GMP,
Excellent communication skills,
Team player with ability to work in a matrix environment, Strong organizational skills.