崗位職責(zé):
1. 負(fù)責(zé)跟進(jìn)、落實(shí)制劑研發(fā)實(shí)驗(yàn)室的規(guī)劃、設(shè)備物料及耗材的采購;規(guī)章制度、良好操作規(guī)范和5S的建設(shè)及監(jiān)督執(zhí)行。
Responsible to follow up and implement the planning of DP R&D lab, procurement of equipment materials and consumables; develop and supervise rules and regulations, good practices and 5S implementation.
2. 負(fù)責(zé)制劑處方的開發(fā)計(jì)劃/方案及其他相關(guān)研究報(bào)告的起草/審核。
Responsible for the drafting/review of formulation development plans/schemes and other related research reports.
3. 負(fù)責(zé)推進(jìn)制劑處方工藝開發(fā)工作,包括早期成藥性研究、臨床制劑處方篩選、工藝優(yōu)化、運(yùn)輸條件、穩(wěn)定性考察等相關(guān)研究方案的制定、實(shí)施、評價(jià)、審核等工作。
Responsible for promoting the development of formulation prescription process, including the development, implementation, evaluation and review of early drug-forming studies, clinical formulation prescription screening, process optimization, transportation conditions, stability investigation and other related research programs.
4. 確保各項(xiàng)實(shí)驗(yàn)按照擬定的計(jì)劃、方案執(zhí)行;控制實(shí)驗(yàn)成本、進(jìn)度和質(zhì)量;審核實(shí)驗(yàn)記錄。
Ensure that all experiments are executed according to the proposed plans and protocols; control the cost, progress and quality of experiments; review experimental records.
5.負(fù)責(zé)制劑項(xiàng)目管理、不斷完善制劑研發(fā)平臺。
Responsible for formulation project management and continuous improvement of formulation R&D platform.
6.負(fù)責(zé)落實(shí)與制劑相關(guān)的IND申報(bào)資料和原始記錄的整理、匯總和審核;配合藥品注冊現(xiàn)場檢查。
Responsible for organizing, summarizing and reviewing information and original records related with DP for the IND filing; cooperate with on-site inspection for drug registration.
任職要求:
1.本科或以上學(xué)歷,生產(chǎn)經(jīng)驗(yàn)豐富者可放寬要求
High school, college or above; the requirement can be relaxed for candidate with rich manufacture experience
2.兩年制劑相關(guān)的工作經(jīng)驗(yàn);優(yōu)先考慮有制劑研發(fā)工作經(jīng)驗(yàn)。
Two years working experience related to DP; priority will be given to those who have pharmaceutical work experience and are familiar with the work flow and equipment operation in the production plant.
3.良好的學(xué)習(xí)能力和表達(dá)能力
Good learning ability and expression ability.
4.熟練使用各種辦公軟件
Proficiency in using various office software.
5.具有良好的語言表達(dá)能力和書面寫作能力
Good language skills and written skills.
6.具有良好的職業(yè)操守,有責(zé)任心及團(tuán)隊(duì)合作精神
Good professional conduct with responsibility and teamwork spirit.