What are your responsibilities?
As Biologic Product Development Lead , you are in charge to
Initiates, directs and executes scientific research for innovation and process improvements;
Responsible for the site Drug Product Development :
Manage formulation development and improvement following Quality by Design approach and according to ICH Q8 regulation;
Lead Failure Mode and Effect Analysis (FMEA) for the drug product formulation, fill and finish process;
Be responsible of the compatibility studies with the manufacturing process materials, including tubing, bags, filters and final container closure;
Knowledge and execution of matrix design for experiments as a part of defining process operating windows and design space;
Build and maintain vendor relationships;
Host technical workshops or meetings for process development groups;
Acts as the technical lead for client development projects, communicates project status internally and externally, and effectively provides technical explanation / rationalization;
Critically analyzes complex data, interprets and integrates experimental results with project objectives;
Writes complex procedural SOPs, and reports;
Accurately reviews batch records and other data, ensuring consistency;
Expert knowledge of scale up principles with respect to formulation, fill & finish;
Troubleshoot and problem solve in order to initiate and execute / monitor corrective actions;
Performs lab overview for client tours and internal clients.
Be the site SME (Subject Matter Expert) for biological drug product development and support the site transition towards biological drug manufacturing :
Define and follow the implementation of the needed laboratory area and equipment to perform biological drug product formulation development, drug product process development and scale-ups;
Collaborate with universities / research centers to ensure up-to-date knowledge of biological drug product development and manufacturing;
According to increasing customers' demand, create and manage a team for the drug product development.
Assist the project management team to determine timeframe, funding and limitations.
Interact routinely with functional leaders at the site along with other sites to ensure alignment with processes and procedures.
Interact with BD (Business Development) team for prospection of new business.
Act as center of expertise for new biological drug development while interacting with customers.
Experience with quality control and quality control tracking systems including change control and deviations.
Supports internal and external audits.
Who are you?
You are graduated as a PhD / master degree in biotechnology , with at least 10 years of laboratory experience, preferably in an industrial setting.
You have an experience in process scale for Biological drug product development including formulation development and drug product process development and an experience in Biological drug product formulation validation , process scale up, and technology transfer .
You have an experience working in a cGMP and GDP environment. Aseptic technique experience is an asset. You have an experience mentoring staff regarding laboratory procedures and scientific projects.