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- Member of technical development teams, technical project sub-teams and participation in meetings including regular update of the resource and time planning forecasts according to project progress.
- Order and plan development and supply activities for internal and external projects.
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- Support the creation and review of Master Manufacturing Records (MMRs) for clinical batches (GMP)
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- Ensure the supervision of conducted trials and developed models with respect to quality of the products as well as the scientific quality of the resulting data.
- Ensure GMP compliant operations when required due to equipment or infrastructure
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Formulation Scientist/Senior Scientist/Principal Scientist - Shanghai, 中国 - Roche
描述
The Position
Primary Purpose of Job (Job Summary) 主要工作目标(岗位简介)
Principle Roles & Responsibilities / Accountabilities
(Major functions of the position)
Represent the formulation function at cross-functional project team on preformulation and formulation related matters and provide necessary support to project teams.
Perform preformulation research on NCE including but not limit to compound pharmaceutical profiling, physicochemical property and solid-state characterization, polymorph/salt/co-crystal screening for phase-appropriate solid form selection.
Serve as a preformulation expert; optimize the in-house capability to create innovative and efficient solutions to specific problems utilizing the state-of-the-art technologies and in-depth scientific knowledge and experience.
Set up and maintain solid state and formulation equipment including XRPD, DCS, TGA, PLM, DVS, PSD etc.; writing relevant instrument user manuals and reports.
Contribute to new chemical entity (NCE) developability evaluation from preformulation and formulation perspective.
Knowledge in preclinical Formulation development and supply to small molecules R&D projects would be a plus.
This including the support of ongoing efficacy, DMPK, and toxicology studies; Make improvements on the existing formulations.
Development of formulations and manufacturing processes for clinical trials and commercialization. This includes:
Participation in non-project-related initiatives or working groups after appointment by the section or department head.
SHE
GMP
Qualification and Experience
Education/Qualifications
Advanced degree in a scientific or relevant discipline or equivalent) with at least 5 years or MS with at least 10 years' working experience in formulation/chemical engineering or related area.
Job Required Competencies
Demonstrated knowledge and experience for formulation development. Capability for fully independent work in all these areas and iIdentify critical physicochemical liabilities & hot spots that may affect design and development.
Solid knowledge on formulation theories and the state-of-the-art technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of instruments (sieving, blending, milling, dry granulation, wet granulations, tablet press, capsule filling, coating, packaging etc.)
Solid knowledge in SHE and cGMP.
Solid knowledge on preformulation theories and technologies would be a plus. Understand solid-state characterization, pharmaceutical profiling, polymorph/salt/co-crystal screening. Understand/interpretation the profiling data generated by XRPD, DSC, TGA, PLM, DVS, IR, PSD, HPLC, Dissolution etc.
Be able to manage project; possess strong problem solving and troubleshooting abilities; be able to manage project; be proactive and self-motivated.
The candidate should be a good team player with good interpersonal communication skills.
Fluent in both written and spoken English; can deliver good presentations in English and Chinese.
Travel Frequency 出差频率
■
<25%
̈
25% - 50%
̈
> 50%
