職位描述
崗位職責(zé):
1、新產(chǎn)品工藝開(kāi)發(fā)與放大轉(zhuǎn)化
New Product Process Development & Scale-up
根據(jù)公司產(chǎn)品規(guī)劃,負(fù)責(zé)固體劑型新產(chǎn)品的工藝落地實(shí)施,與產(chǎn)品研發(fā)負(fù)責(zé)人緊密協(xié)作,推進(jìn)工藝從中試階段向規(guī)?;a(chǎn)的順利轉(zhuǎn)化;統(tǒng)籌并協(xié)調(diào)工藝轉(zhuǎn)化過(guò)程中與生產(chǎn)、質(zhì)量、法規(guī)、采購(gòu)等相關(guān)部門(mén)的技術(shù)需求,確保工藝方案的可行性與穩(wěn)定性。
According to the company’s product roadmap, lead the process development and implementation of new solid dosage form products. Work closely with product R&D owners to ensure smooth process transfer from pilot scale to commercial manufacturing, and
coordinate with Manufacturing, Quality, Regulatory, Procurement, and other relevant functions to ensure feasibility and robustness of process solutions.
2、 已上市產(chǎn)品工藝優(yōu)化與技術(shù)升級(jí)
Process Optimization & Technical Upgrading of Launched Products
負(fù)責(zé)公司已上市產(chǎn)品的工藝優(yōu)化與升級(jí)相關(guān)技術(shù)研究工作,包括但不限于工藝參數(shù)優(yōu)化以提升生產(chǎn)效率與產(chǎn)品質(zhì)量穩(wěn)定性、新增或替代供應(yīng)商的工藝驗(yàn)證、技術(shù)轉(zhuǎn)移及價(jià)值鏈優(yōu)化相關(guān)的工藝支持工作。
Responsible for continuous process optimization and technical upgrading of launched products, including but not limited to process parameter optimization to improve efficiency and quality consistency, process validation for new or alternative suppliers, technology transfer, and other process-related support along the value chain.
3、3. 新品研發(fā)階段的工藝與原輔料支持
Process & Raw Material Support in NPD Stage
支持研發(fā)部門(mén)在新產(chǎn)品開(kāi)發(fā)階段的工藝研究工作,包括原輔料篩選、工藝可行性評(píng)估及相關(guān)技術(shù)支持,確保產(chǎn)品設(shè)計(jì)與后續(xù)生產(chǎn)工藝的有效銜接。
Provide process-related technical support during the new product development stage, including raw material and excipient screening, process feasibility assessment, and other related activities, to ensure alignment between product design and manufacturing processes.
4、新設(shè)備及新原料的工藝驗(yàn)證支持
Process Verification for New Equipment & Materials
支持相關(guān)部門(mén)開(kāi)展新設(shè)備、新原料的工藝驗(yàn)證工作,參與驗(yàn)證方案制定、實(shí)施及結(jié)果評(píng)估,為產(chǎn)品順利導(dǎo)入生產(chǎn)提供專業(yè)技術(shù)支持與可行性建議。
Support relevant departments in process verification of new equipment and new raw materials, including participation in validation planning, execution, and evaluation, and provide technical support and feasibility recommendations to ensure smooth product manufacturing.
5、多劑型工藝能力支持與對(duì)外合作項(xiàng)目
Multi-dosage Form Capability & External Collaboration Support
熟悉其他食品劑型及其相關(guān)工藝技術(shù),在對(duì)外合作或聯(lián)合開(kāi)發(fā)項(xiàng)目中,提供工藝層面的專業(yè)支持,協(xié)助推進(jìn)合作產(chǎn)品的開(kāi)發(fā)與落地。
Maintain working knowledge of other food dosage forms and related processes, and provide process expertise in external collaboration or co-development projects to support successful product development and implementation.
任職資格:
1.食品學(xué),營(yíng)養(yǎng)學(xué)或相關(guān)專業(yè)本科以上。
Bachelor 's degree or above in Food Science and Engineering,Nutrition etc;
2.碩士4年/本科6年以上,在食品、營(yíng)養(yǎng)食品或保健食品領(lǐng)域從事產(chǎn)品開(kāi)發(fā)及工藝研究相關(guān)工作經(jīng)驗(yàn)。
At least 4 years of relevant working experience with a Master’s degree, or 6+ years with a Bachelor’s degree, in product development and process engineering within the food, nutritional food, or dietary supplement industry.
3.熟練掌握營(yíng)養(yǎng)及保健食品相關(guān)劑型的產(chǎn)品開(kāi)發(fā)專業(yè)知識(shí),尤其是固體劑型(如粉劑、片劑、膠囊等),包括配方設(shè)計(jì)、生產(chǎn)設(shè)備及工藝、質(zhì)量控制等;
Solid professional knowledge in the development of nutrition and dietary supplement products, especially solid dosage forms (e.g. powders, tablets, capsules), including formulation design, manufacturing processes, equipment, and quality control;
4.熟悉新品開(kāi)發(fā)的完整流程,包括但不限于配方設(shè)計(jì)、原料篩選、小試、工藝研究與中試放大、產(chǎn)品檢測(cè)、穩(wěn)定性研究等;
Proven experience in independently completing or leading product development projects, with strong cross-functional communication and collaboration skills, and the ability to drive product innovation and implementation based on market needs;
5.具備獨(dú)立完成或主導(dǎo)產(chǎn)品開(kāi)發(fā)項(xiàng)目的成功經(jīng)驗(yàn),具有良好的跨部門(mén)溝通與協(xié)作能力,能夠結(jié)合市場(chǎng)需求推動(dòng)產(chǎn)品創(chuàng)新及項(xiàng)目落地;;
Familiar with Chinese regulatory requirements;
6.熟悉中國(guó)食品及保健食品相關(guān)法律法規(guī)及監(jiān)管要求;
Familiar with Chinese regulations related to food and dietary supplements;
7.熟悉研發(fā)數(shù)據(jù)管理與系統(tǒng)管理;
Familiar with R&D data management and system management;
8.英語(yǔ)六級(jí)及以上水平;
CET-6;
9.具備良好的跨部門(mén)溝通與協(xié)作能力,工作態(tài)度積極,待人真誠(chéng)友好,具備較強(qiáng)的責(zé)任心和主動(dòng)性。
Strong cross-functional communication and collaboration skills, proactive working attitude, and a high level of responsibility and professionalism.