Senior Portfolio Development Coordinator
Job Description
Job Purpose:
The role is responsible for the technical and administrative management of products transfer projects. This includes new launches, localization, formulation development and toll in products. The role is also responsible for artworks update and follow up process.
KEY RESPONSIBILITIES AND DUTIES:
Prepare CMC file for new products and Generics:
*Full responsibility for 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)
*Ensure completeness of stability files for three validation batches of new products
Prepare preliminary technical evaluation and feasibility of manufacturing:
*Perform preliminary technical evaluation and feasibility for new product (manufacturing process, specifications, analysis, analytical method validation and stability)
*Create a preliminary Cairo site manufacturing process flowchart
Sourcing cases: Complete sourcing cases & contracts
Manage Transfer Projects:
*Set up a project plan for each transfer
*Participate in the projects (local manufacture) managed by the affiliate business development, as required
*Provide all necessary technical and logistics support for the team
*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)
*Create a regular communication channel to ensure all stakeholders are updated of the project progress & obstacles
*Ensure fulfilling all regulatory requirements related to transfer projects
*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
Act as the focal point for artwork management process
Organize monthly SPRINT meeting for governance of all ongoing projects
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
HSE Responsibilities in case joining HSE Excellence team:
*Facilitate and guide the employees to implement the HSE&En. Policies.
*Implement all applicable standards and guides of Sanofi-Aventis in his/her area
*Ensure of complying with all legal and Sanofi-Aventis requirements
*Lead his/her team to implement the HSE & EnMS PASS
*Train his/her team on HSE & EnMS procedures, SOP’s and MSDS
*Report any accidents/incidents in his/her area to the HSE department
*Lead his/her team for investigate accidents/incidents to define the root cause
*Support the area manager in taking the corrective and preventive actions to eliminate recurrence of any Environmental or Energy nonconformance
*Support the area manager in taking the corrective and preventive actions to eliminate recurrence of any accident/incident
*Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area
*Lead the team of his/her area for doing full risk assessment and Environmental aspects studies
*Define and control the required PPE’s for his/her area
*Define the list of CMR and its operational control for Quality labs and production areas
*Control the first aid kits in his/her area
*Leading his/her team in controlling the significant hazards /aspects and Energy use
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: 5-7 years of related industrial experience
Special Knowledge/Skills:
*Excellent communication and presentation skills
*Well developed planning and organization skills to manage multiple projects simultaneously
*Results-based leadership skills
*Ability to function within a diverse team and leverage and learn from the variety of backgrounds and experiences
*Problem solving skills
*Experience with Microsoft Office tools
*Knowledge of manufacturing, analytical & regulatory regulations (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
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
