Principal Scientist, Formulation Development

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

Responsible to provide effective technical leadership in achieving scientific excellence, planning, co-ordination and delivery of drug product development projects to meet business objectives. With demonstrable CMC experience, support the functional matrix team to develop robust and phase appropriate drug product development strategies.

Essential Functions/Responsibilities

• Provides technical mentorship and coaching to junior members of the team and identifies appropriate training courses to upskill the Team.


• Ensures development tasks within the group are tracked and delivered in accordance with project timelines.


• Proactively works with Regulatory team to define requirements for regulatory submissions.


• Fosters and promotes a high degree of innovation and forward-thinking within the team. Maintains industry knowledge and keeps abreast of relevant new technologies.


• Ensures all aspects of quality are considered within own and junior scientists work and works with a quality mindset suited to the stage of the projects and nature of the work.


• Ensures that the overall health, safety, security, and environmental protection levels are kept to a high standard in the group. The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the role.


• Ensures training records are kept up to date in accordance with company procedures.


• Delivers and oversees the pre-clinical and clinical formulation development through rational experimental design, thoughtful execution, and clear data interpretation.


• Oversees the technology transfer activities at all scales (both internally and externally) and has an ability to proactively identify issues and put mitigation in place.


• Efficiently interacts and collaborates with external vendors to achieve project goals.


• Identify gaps in internal formulation capabilities and where appropriate lead an effort to implement suitable technologies.


• Authors and/or reviews technical protocols, scientific reports, and present technical datasets


• Reviews the effectiveness of current processes and leads/supports process improvements.


• Interacts with team members and peer managers, across the functional area, other company areas, or external stakeholders.


• Provides good quality communication to both line manager and junior members of the team.


Required Knowledge, Skills, and Abilities

• Has proven track record of formulation design, development, scale up and trouble shooting.


• Has comprehensive understanding of ICH guidelines and pharmacopoeia requirements.


• Good knowledge of statistical design of experiments.


• Able to independently define the required work based on the objective(s) and lead a co-operative effort among a team or group of individuals.


• Acts as a role model within the department and fosters a positive attitude towards challenges and change.


• Supports and influences others within the department to achieve high standards of quality and excellence.


• Fosters a culture of accountability, empowerment and proactivity within team.


• Possesses good communications skills with an ability to adapt style and content to address the needs of the situation or audience.


• Able to challenge the status quo and implement a culture of continuous improvement.


Required/Preferred Education and Licenses

• Degree level of above with suitable experience in the relevant field


• Experience of contributing to regulatory submissions - desirable


Jazz Pharmaceuticals is an Equal Opportunity Employer.
,

Brief Description:

Responsible to provide effective technical leadership in achieving scientific excellence, planning, co-ordination and delivery of drug product development projects to meet business objectives. With demonstrable CMC experience, support the functional matrix team to develop robust and phase appropriate drug product development strategies.

Essential Functions/Responsibilities

• Provides technical mentorship and coaching to junior members of the team and identifies appropriate training courses to upskill the Team.


• Ensures development tasks within the group are tracked and delivered in accordance with project timelines.


• Proactively works with Regulatory team to define requirements for regulatory submissions.


• Fosters and promotes a high degree of innovation and forward-thinking within the team. Maintains industry knowledge and keeps abreast of relevant new technologies.


• Ensures all aspects of quality are considered within own and junior scientists work and works with a quality mindset suited to the stage of the projects and nature of the work.


• Ensures that the overall health, safety, security, and environmental protection levels are kept to a high standard in the group. The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the role.


• Ensures training records are kept up to date in accordance with company procedures.


• Delivers and oversees the pre-clinical and clinical formulation development through rational experimental design, thoughtful execution, and clear data interpretation.


• Oversees the technology transfer activities at all scales (both internally and externally) and has an ability to proactively identify issues and put mitigation in place.


• Efficiently interacts and collaborates with external vendors to achieve project goals.


• Identify gaps in internal formulation capabilities and where appropriate lead an effort to implement suitable technologies.


• Authors and/or reviews technical protocols, scientific reports, and present technical datasets


• Reviews the effectiveness of current processes and leads/supports process improvements.


• Interacts with team members and peer managers, across the functional area, other company areas, or external stakeholders.


• Provides good quality communication to both line manager and junior members of the team.


Required Knowledge, Skills, and Abilities

• Has proven track record of formulation design, development, scale up and trouble shooting.


• Has comprehensive understanding of ICH guidelines and pharmacopoeia requirements.


• Good knowledge of statistical design of experiments.


• Able to independently define the required work based on the objective(s) and lead a co-operative effort among a team or group of individuals.


• Acts as a role model within the department and fosters a positive attitude towards challenges and change.


• Supports and influences others within the department to achieve high standards of quality and excellence.


• Fosters a culture of accountability, empowerment and proactivity within team.


• Possesses good communications skills with an ability to adapt style and content to address the needs of the situation or audience.


• Able to challenge the status quo and implement a culture of continuous improvement.


Required/Preferred Education and Licenses

• Degree level of above with suitable experience in the relevant field


• Experience of contributing to regulatory submissions - desirable


Jazz Pharmaceuticals is an Equal Opportunity Employer.


• Has proven track record of formulation design, development, scale up and trouble shooting.


• Has comprehensive understanding of ICH guidelines and pharmacopoeia requirements.


• Good knowledge of statistical design of experiments.


• Able to independently define the required work based on the objective(s) and lead a co-operative effort among a team or group of individuals.


• Acts as a role model within the department and fosters a positive attitude towards challenges and change.


• Supports and influences others within the department to achieve high standards of quality and excellence.


• Fosters a culture of accountability, empowerment and proactivity within team.


• Possesses good communications skills with an ability to adapt style and content to address the needs of the situation or audience.


• Able to challenge the status quo and implement a culture of continuous improvement.


Required/Preferred Education and Licenses

• Degree level of above with suitable experience in the relevant field


• Experience of contributing to regulatory submissions - desirable
  
  Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.