Group Lead, Formulation and Preformulation (职位编号：08492444)

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.

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As a key member of TRD management team, contribute to department operations

and people development.

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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.

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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

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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.

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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.

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