Within the framework of LONZA’s general policies, the position owner has a role of:
Managing the multidisciplinary pharmaceutical development team of technicians and formulation specialists;
Planning and managing the pharmaceutical development labs, non GMP areas and related equipment in accordance with Lonza quality standards and expected business growth;
Leading the formulation development, the development of pharmaceutical dosage forms and the process development in accordance with customers’ project plans and internal objectives/R&D technologies;
Capitalizing on a network of internal and external experts to utilize Lonza’s unique know how in Lipid-Based Formulations, Solid Dosage Forms, Capsule Drug Delivery Systems and other technologies as appropriate;
Defining and implementing policies and actions to maintain the highest level of quality and safety in its area of responsibilities.
The main responsibilities are as follows:
Leading pharmaceutical development according to customer requirements:
Serve as representative and scientific leader for projects and develop the team in this specific role;
Define the pharmaceutical development strategy according to the target product profile;
Establish pharmaceutical development plan and work programs (objective, methods and timeframe) in accordance with the deadlines communicated to the customer and the project plan. Define formulation specialists and technicians programs accordingly;
Develop formulations according to customer requirements and internal Lonza’s technologies and related requirements;
Perform at least weekly follow up of the projects to ensure deadlines communicated and work plans are respected;
Oversee scientific presentations, protocols and reports from the team for customers (formulation development and manufacturing of technical batches);
Write pharmaceutical development reports for submission to Health Authorities;
Interact with customers for technical information sharing and/or issue resolution.
Conceptualize, design, and apply new technologies into customer projects:
Suggest improvements regarding products, processes, methods or equipment in order to sustain Lonza’s quality and productivity objectives;
Suggest non-customer programs to broad Lonza’s knowledge of established and innovative technologies;
Consolidate the processes and write protocols in view of technology transfer and scaling-up;
Represent the Product Development Director as necessary on pharmaceutical project matters;
Prepare and present posters and oral presentations at pharmaceutical congresses;
Communicate efficiently with all people involved (internal and external);
Provide all necessary technical solutions and scientific support to the Production departments;
Manage the pharmaceutical developments labs and non GMP areas to sustain the expected business growth.
Supervise with the Quality Assurance Responsible the quality system of the Pharmaceutical Development team;
Manage the quality documentation writing (Standard Operating Procedures, Standard Operating Instructions, equipment qualification protocols and reports);
Make sure that technicians and formulation specialists’ training is adequate for the experimental work required;
Ensure that all activities are conducted in safe and professional manners in accordance with Lonza and department policies, SOP’s and cGMP’s.
Guarantee raw material quality:
Identify raw material suppliers using the internal or external network;
Contact raw material suppliers, identify raw materials needed for formulation applications, establish regular contact in order to be up-to-date;
Verify the raw material adequacy, regulatory status, gather all necessary toxicological data.
Manage the Pharmaceutical Development team:
Organize and supervise the work of the Pharmaceutical Development team;
Train and coach new colleagues;
Define the team training requirements and participate in the training of colleagues;
Develop colleague engagement of all team members and communicate efficiently within the team;
Make sure all team members are respecting Quality Standards, Environment Health & Safety regulations and instructions.
Make the customers’ results and internal information available for colleagues and management;
Report daily to the Director, Product Development and write monthly report to management as defined;
Report monthly operational KPIs.
TRAINING AND EXPERIENCE
PhD preferred, pharmacist, or engineer. Background in Lipid Based Formulation is an asset;
Professional record of achievement in pharmaceutical development.