Company?Profile:
美資500強生物科技公司，專業(yè)從事生物產(chǎn)品的技術開發(fā)、研制、生產(chǎn)、銷售及技術轉(zhuǎn)讓，在行業(yè)中處于領先地位。
Responsibility:
1.?Manage?a?capital?project?(3X?of?current?operational?capacity)?from?design,?scale?up,?technology?transfer,?procurement,?construction,?validation,?regulatory?approval,?financial?control?and?product?launch.
2.?Demonstrated?project?management?skills?with?strong?ability?to?negotiate?and?leverage?the?capability?and?resources?in?a?highly?matrixes?environment?including?external?contractors?and?various?functional?SMEs.
3.?Strong?organizational?skills;?ability?to?prioritize?and?manage?complex?processes/projects?with?many?stakeholders.
4.?Handle?complex?projects?and?assures?delivery?of?the?improvements?in?a?cross-functional,?timely?and?cost-efficient?manner.
5.?Work?with?R&D?Technology?operations?group?to?scale?up?the?processes?and?equipment.
6.?Technical?knowledgeable?of?China?FDA/EMEA/?US?FDA?biologics?and?pharmaceuticals?regulatory?requirements.
7.?Basic?technical?understanding?of?biopharmaceutical?processing?and?controls:
7-1.?Aseptic?processing?experience.
7-2.Protein?purification?and?or?chemical?processing.
7-3.?Equipment,?facility?and?utility?engineering.
7-4.?Production?process?control,?materials?and?personnel?flow?efficiency?in?a?highly?regulated?GMP?environment.
7-5.?Capacity?planning?and?utilization?management.
7-6.?General?process?and?equipment?validation?management.
7-7.?GMP?regulations?and?interpretations.
Requirements:
1.?Bachelor's?degree?in?Engineering?and?/or?a?related?science?field,?Master?degree?is?a?plus.
2.?Minimum?of?10?years’?experience?at?plant?level?operations.
3.?Excellent?communication?skills,?English?and?Chinese?fluency?strongly?preferred.
4.?Strong?leadership?experience?with?a?track?record?of?developing?and?mentoring?teams.