Reporting into the Exec Director Manufacturing Sciences within the Process Development and Manufacturing Sciences (PDMS) group the role will provide scientific and technical leadership to our external commercial partners for large and/or small molecule DS/DP manufacturing;
This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting to drug substance, drug product and finished product manufacturing activities for large and/or small molecules. This responsibility includes all process validation activities;
Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and supporting CMC aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including R&D, external manufacturing and Quality, working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control;
The role works in close collaboration with the product team’s Project lead who is the primary owner of the team processes, tools, metrics and all aspects of project management to ensure successful manufacture and supply of product to Patients.
Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development/support objectives;
Lead development, maintenance and continuous improvement of process validation program for all DS and DP manufacturing processes. Provide technical input to Process Development for defining the critical process parameters of new processes;
Experience of CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles;
Key member of the product External Manufacturing Product Team. Prioritizes technical or manufacturing issues for discussion & decision by the team;
Works to the guidelines set out in the Product team charter;
Lead the technical agenda & relationship between the team and with the relevant CMOs technical team at the site of manufacture;
Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences;
Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead;
Support other Product/Process Development and Manufacturing areas to ensure a smooth transfer of technologies and products to contract sites;
Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures;
Take ownership of planning, executing and reporting for all life cycle management projects and technology transfers in support of process improvement and new product introductions;
Lead the development of knowledge of new pharmaceutical manufacturing processes as required in line with Jazz business objectives;
In conjunction with Quality Operations ensure that CMOs are qualified and approved;
Ensure Drug Substance, Drug Product, label & packaging and primary product contact materials are manufactured on time to the required quality;
Collaborates with Development Team Leads to map the transition of responsibility for manufacturing from the development team to External Manufacturing Product Team as planning for Phase III supplies begins;
Lead the Product team to identify and drive manufacturing process improvements and change management within CMOs.
Required Knowledge, Skills, and Abilities:
Wide-ranging experience in pharmaceutical manufacturing with a strong background in large and/or small molecule manufacturing technologies;
Excellent organizational, verbal, communication and presentation skills;
Ability to effectively lead and participate on multi-disciplinary teams;
Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations.
Education, Experience and Licenses:
BSc in life sciences or engineering;
Advanced degree (MSc, PhD) desirable;
Experience working in cross functional teams in a pharmaceutical industry environment;
Strong record of achievement in pharmaceutical manufacturing environment;
Proven hands-on experience in GMP manufacturing and validation activities;
Experience of both small and/or large molecule technologies, with demonstrated technical expertise in process development and new product introduction;
Demonstrated track record of training and coaching colleagues to improve overall team process knowledge;
Proven project management skills for technical programs ideally complemented with Project Management qualification;
Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable.
Description of Physical Demands:
Responsibilities may require working outside of “normal” hours, in order to meet business demands.