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The Position
Primary Purpose Of Job (Job Summary)
- Conduct preformulation and formulation research to support Roche China (CICoR) portfolio assets and technical development. Serve as a resident preformulation expert, optimize the in-house capability to create innovative and efficient solutions to specific problems
- Lead the Drug Product Teams (DPL) for technical drug product development for clinical study and commercialization
- 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
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:
- Order and plan development and supply activities for internal and external projects
- Supervision of technical batches manufactured in the GMP area in CDMO
- Cooperate with the responsible person for manufacturing for the production of clinical batches (GMP), in particular planning, handover of project data and time requirements for manufacturing and delivery
- Support the creation and review of Master Manufacturing Records (MMRs) for clinical batches (GMP)
- Responsibility for the project-related coordination for the timely manufacturing and delivery of clinical batches
- Ensure the transfer of knowledge for the creation of master manufacturing records (MMRs) for transfer, registration and validation batches (PPQ). If necessary, support with the creation, review and approval
- Define IPC test methods for dosage forms, their starting materials and intermediates
- Establish and monitor stability testing in collaboration with analytical development and the stability group
- Evaluation of suitable primary packaging materials in cooperation with packaging development and, if necessary, support of device development in the evaluation of devices
- Contribute to the development of cleaning methods in close collaboration with the colleagues of the Cleaning Assessment Group in the Pilot Plants & Systems section
- Responsible for project-related change management (initiation, creation, execution and implementation of change control documents)
- When needed, assist in the procurement, qualification and commissioning of equipment and machines
- Participation in non-project-related initiatives or working groups after appointment by the section or department head
SHE
- Implement and fully comply with all Roche policies, procedures and standards in the areas of safety, health and environment protection
- Maintain order and safety through compliance to operating and safety regulations
- Responsible for conduction of safety training related to the handled substances (SGU) for assigned projects
GMP
- 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
Education/Qualifications
Qualification and Experience
Advanced degree in a scientific or relevant discipline (Ph.D. 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
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an Equal Opportunity Employer.