Portfolio Development Specialist At Sanofi
JOB PURPOSE:
The role is responsible for providing technical and administrative support to products transfer projects. This includes new launches, localization, formulation development and toll in products. The role also takes part in the artwork update and follow up process.
KEY RESPONSIBILITIES AND DUTIES:
*Support in the preparation of CMC file for new products and generics
*Prepare all initial technical data (such as composition formula, specs and COA for active and inactive materials and stability data and tables)
*Prepare stability files for three validation batches of new products
*Compile all data needed for feasibility assessment of new products
*Participate in setting up a project plan for each transfer
*Coordinate purchase processes and solve all supplier-related issues
*Ensure proper alignment of all projects’ stakeholders; finance, DRA, procurement, business unit, plant supply chain, RSO, quality assurance, quality control, production, legal, customer (if applicable)
*Maintain a proper documentation system for all projects
*Collaborate with the team for resolution of issues that arise, to mitigate any risk of project completion according to the pre-set timelines
*Assist in the artwork management process
*Participate in the monthly SPRINT meeting and follow up for completion of actions that arise
*Report the progress of projects monthly in a clear actionable format
HSE Responsibilities:
*Commitment to the appropriate PPE use
*Follow the approved HSE policy and requirements
*Follow the statutory legislation concerning Health, Safety and environmental law
*Waste management according to the approved system
Others:
*Perform other duties as assigned.
*Respect of company’s values, code of ethics and social charter.
*Respect of personal data protection charter.
*Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education: B.Sc. of Pharmaceutical science
Related Experience: 3-5 years of related industrial experience
Special Knowledge/Skills:
*Communication skills
*Knowledge of regulatory requirements
*Planning
*Computer skills: High in Microsoft office
*Exposure to SAP / supply systems
*Excellent command of English language, French will be an asset
*Ability to work under pressure
*Pro-active & problem solver
*Team player
*Experience with Microsoft Office tools
*Pharma industry background (desirable)
Competencies:
*Stretch to go beyond the level we have operated at up until now
*Take actions instead of waiting to be told what to do
*Act in the interest of our patients and customers
*Put the interests of the organization ahead of my own or those of our team
*Act for Change, Strive for results, Cooperate Transversally, Commit to Customer
*Think Strategically, Lead Teams, Develop People, Make Decisions