Associate Director, R&D - Process Chemistry
Jazz Pharmaceuticals
Sittingbourne, United Kingdom
The Associate Director, R&D – Process Chemistry heads the process research and development team within the Discovery and Medicinal Chemistry group at Kent Science Park, adopting a leadership and technical role and working together with other CMC functions to advance drug candidates from lead optimisation to GLP Tox.
Essential Functions
- Lead a group of scientists and is accountable for the development activities in the Process Development Team.
- Analyse Evaluate medicinal chemistry synthetic procedures to redesign and/or identify scalable processes covering supply of early development activities up to GLP Tox.
- Plan, agree, resource and execute the optimization of a synthetic route identifying clear deliverables and milestones in accordance to with the overall molecule project plan.
- Identifies intellectual property generation opportunities and drives innovation within the team.
- Presents regularly project updates to the department and CMC teams with a clear focus on prioritization and delivery.
- Acts as the Drug Substance Lead and SME, working closely with other early CMC functions as including analytical, preformulation, biopharmaceutics Medicinal Chemistry and toxicology.
- Promotes a purpose driven team environment, with a focus on safety within the department.
- Identifies procedural and technical gaps within the department and drives implementation of optimized procedures.
Required Knowledge, Skills, and Abilities
- Relevant pharmaceutical industry experience within a Discovery/Early Development setting with a broad theoretical and practical understanding of early drug development and drug candidate nomination criteria.
- Good understanding of the key attributes that make a potential drug suitable for IND-enabling/clinical development.
- Scours relevant scientific literature within field and surveys broadly beyond own discipline/field.
- Excellent management skills, including planning and resource allocation.
- Excellent verbal and written communication skills, including the ability to communicate effectively with external partners.
- Strong IT skills and an ability to use key software packages to produce, present and analyse data and produce compelling materials for internal and external use
- Demonstrated ability to lead projects from inception to completion, coordinating the efforts of a team within budget, timelines and regulatory requirements.
- Partner with Pharmaceutical Development on API development approaches to mitigate risk as candidates progress.
- Displays the attributes encompassed in Jazz’s values and encourages their development in others.
Required/Preferred Education and Licenses
- MSc/PhD in a chemical or pharmaceutical subject, ideally with postgraduate qualification in chemical synthesis, drug substance development or related discipline.
- Knowledge of quality and regulatory standards within the Pharmaceutical Industry in early phases and experience of applying those into drug development projects.
- cGxP awareness and experience applying this within an R&D environment.
- Will have Ideally has experience with statistical procedures and software, particularly DoE and multivariate analysis.
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