上海招聘

The Position

You are a principal scientist who will lead and manage the Preformulation and Analytics group to provide full analytical and preformulation support to Roche portfolio assets. Further responsibilities are;

• Oversee project execution and provide technical expert support from preformulation and analytics perspective.


• Play key roles in coordinating preformulation and analytics related activities cross functions, between global and local, as well as with external partners.


• Preformulation support for projects.


• Design and conduct pharmaceutical profiling experiments for developability evaluation for leading compounds/candidates


• Lead or involve project technical discussion and actively contribute to lead optimization and candidate development.


• Design and perform phase-appropriate polymorph/salt screening for leading compounds/candidates to ensure appropriate physical form is always used for in vivo/in vitro studies.


• Collaborate with process research and formulation group to develop formulation to support DMPK/Toxicity activities


• Analytics support for Process R&D and Formulation R&D.


• Design and conduct experiments to support programs/projects in a timely manner


• Lead and oversee analytical support such as structure identification, method development to medicinal chemist and process chemist in drug discovery and development activities


• Oversee analytical method development and validation, release testing, specification set up, stability study, manufacturing, and process/formulation development for drug substance and product.


• Prepare the analytical sections of documents for DS/ DP to support regulatory filings of pRED China projects


• Management of preformulation and analytical development team.


• Lead and manage preformulation and analytics group


• Provide mentoring, training and coaching to team members


• Develop and retain key talents and hire new talents if needed


• Further strengthen capability and enrich skill sets of preformulation and analytics group


• Plan and control group budget


• Daily manage various areas such as equipment, material and documentation etc. and be responsible for the proper operation of Preformulationa and analytics group.


• Work with Department Head to foster open, energetic, productive and initiative culture


• Management of external partnership.


• Leverage external resource and expertise for the purpose of enhancing internal capability and project delivery


• Establish and maintain good relationship with external partners


• Monitor and manage the progress and quality of outsourcing project and assure the timeline and delivery quality can meet Roche requirement and standard


• Represent as key contact person with global preformulation function coordinating for related activities.


• Represent preformulation and analytics to actively participate relevant internal and external symposia/conferences for knowledge sharing and scientific level improvement


• As a key member of CMC management team, contributes to department development and people development.


• Responsible for drafting, reviewing, and implementing of analytical related SOPs or guidelines, as well as maintaining & troubleshooting of all formulation related analytical instruments.


• Be responsible and ensure the Lab safety of Preformulation and Analytics comply with Roche SHE policy.
  

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have a PhD degree in analytical chemistry/pharmaceutical science (or closely related field) with at least 6 years’ working experience in pharmaceutical industry and at least 4 years of preformulation or analytical experience. Other requirements are;

• Integrity, Focus on Value & the Customer, Align for Success, Deliver Results, Learn for the Future


• Solid knowledge on the state-of-the-art preformulation & analytical theories and technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of analytical instruments (HPLC, GC, LCMS, XRPD, PLM, IR, UV, DSC, TGA, Dissolution etc).


• Design and perform comprehensive physicochemical and/or solid state property characterization of new molecular entities (NMEs) to evaluate the drug like properties and develop-ability. Identify critical physicochemical liabilities and hot spots that may impact on development.


• Design and perform comprehensive polymorph/salt/cocrystal screening for new molecular entities to identify stable polymorph/appropriate salt/cocrystal for further development.


• Demonstrated analytics knowledge and experience for drug substance and drug product development, which includes analytical testing method development & validation, stability studies, impurity profiling, dissolution method development & validation, and related specification setting, etc.


• Current knowledge and hands-on experience in cGMP & GLP and experience in IND/NDA dossier preparation would be a plus.


• Team management experience is must. Must be a good team player with enterprise thinking and excellent interpersonal communication skills.


• Must be an independent researcher; must be capable of leading and managing preformulation and analytics activities; must possess strong problem solving and troubleshooting capabilities. Must be proactive and self-motivated.


• Fluent in both written and spoken English; can deliver good presentations in English and Chinese.
  

The next step is yours. To apply today, click on the "Apply online" button below.


Who we are

At Roche, 85,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.


Roche is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

More Information related to This Position
Clink Here

罗氏研发（中国）有限公司，位于上海张江高科技园区，是中国第一家由跨国制药企业独资拥有的药物研发中心，我们将通过尝试新的药物研发途径，为国内乃至国际市场提供具有临床差异性的药物。经过5年的发展，罗氏研发（中国）有限公司从早期药物发现工作起步，建立了从早期研究到早期开发全功能的药物研发业务部门，成为一个在中国拥有大批业内专家和广泛合作伙伴的药物研发组织。我们正在寻找药物研发行业内的领军人物加入我们，让我们共同创造医疗保健领域的美好明天。