Group Lead, Formulation and Preformulation

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Die Position

Job Summary

The Preformulation and Formulation group within Technical Research and Development (TRD) Department is responsible for the development and supply of drug product for all preclinical, GLP toxicological and early clinical projects in the small molecule portfolio of China Innovation Center of Roche (CICoR). The leader of this group plays a key role in ensuring the delivery of portfolio objectives and enhancing the capability of the staff.

Roles, Responsibilities and Accountabilities

• Lead a group of 4-5 scientists in the preformulation/solid state sciences/formulation area. Be responsible for ensuring discipline excellence, managing staff workload and fostering a positive team culture with a growth mindset.
• Provide leadership and expert scientific guidance to teams; develop and continuously optimize the group's best practices in workflow; deliver results that meet quality and productivity objectives.
• Promote innovation to transform novel molecules to potential medicines.
• As a key member of TRD management team, contribute to department operations and people development.
• Be accountable for the DP activities of the local R&D small molecule NCE portfolio; including compound profiling, API salt and form evaluation and selection, PD/PK/tox formulation development and supplies, as well as early clinical formulation development and supplies.
• Partner with other lines within TRD in building collaborative high performing department project teams.
• Represent formulation function on cross-functional project teams and technical development teams. Coordinate DP efforts and enable functional support within project timeline and budget requirements.
• Advise senior management on project strategies and scientific de-risking. Foster strong relationship with local and global partner functions for the fit-for-purpose development of formulation that is bioavailable, stable and manufacturable.
• Facilitate and mentor group members in effective communication and teamwork within the group, project teams, and intra and inter- department functions (such as API synthesis, Analytics, Medicinal Chemistry, Biology, DMPK, Toxicology, Clinical and Regulatory).
• Act as a link between CICoR and Roche global functions and a coordinator to align local technical practice to global standards.
• Perform CRO/CMO scouting and selection activities; manage outsourced non-GMP and GMP activities at CRO/CMOs per project needs.
• Ensure and monitor adherence to GLP, GMP and Regulatory Standards as applicable.

Qualification and Experience

Education/Qualifications

• Ph.D. degree in pharmaceutics/chemical engineering or related areas with at least 8 years (postgraduate) of increasing responsibility in small molecule drug product formulation, ideally with working experiences in Europe or the US.

Job Required Competencies

• Demonstrated technical expertise: strong theoretical understanding and practical experiences in the area of SM NCE drug product development and manufacturing: including preformulation, solid state sciences, preclinical and GLP toxicological formulation, and Ph1 clinical oral solid dose formulation.
• Sound knowledge of biopharmaceutics, DMPK and PK-PD that is critical for selection of optimal clinical candidate and for development of fit-for-purpose formulation.
• Experience in regulatory guidelines and in IND/IMPD authoring and submissions.
• Knowledge and understanding in GLP and GMP requirements and quality assurance concepts.
• Demonstrated understanding of technical development in the discovery/early clinical phase; experience in working and contributing within a CMC/technical development team.
• Experience in managing an internal team and external resources.
• Must be a strong team player and capable leader. Experience in leading teams/groups is required.
• Good interpersonal communication skills. Fluency in both written and spoken English is required.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

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