宁波招聘

职位描述：
Description:
?Responsible for the production of drug substance to enable reliable clinical supplies according to cGMP.
?Coordination of resources and equipment to ensure timely material supply. Ensuring GMP readiness of facility, personnel and equipment,Identify savings and potentials within procedures and adapt if necessary.
?Reposible for robust DSP processes for therapeutic proteins and monoclonal antibodies using platform mammalian cell culture purification techniques. Overall responsibility for all facility activities and regular alignment with Head of GMP DSP and/or Head of Clinical Production.
?Support regulatory dossiers and CTA/IND application (support tech RA). Run interfaces with QC and QA during all GMP operations.
?Participate in project team meetings internally and externally and close communication with client or development labs to ensure smooth transfer of processes. As Core project team member assemble and coordinate Subteam-meetings for DSP aspects.
?Support drafting and reviewing of CMC sections for filings (CTA, IND, BLA, etc.) as part of the project team.


Duties & Responsibilities:
?Responsibility and coordination of GMP DSP process team including all downstream purification steps and in-process controls. Engage GMP operation and ensure safe processing and safe handling within his/her team
?Expert for DSP topics within Mammalian Platform Purification Process. Author DSP related GMP documentation and CMC DSP section for filing
?Accountability for delivering results according to project timeline with quality practices that strictly adheres to cGMP and SOPs


Requirements:
?PhD or Master degree in biology, biochemistry, chemistry or engineering, and more than 2 years (3 years for Master degree) of relevant industry experience
?Competencies to develop a highly motivated team and development of employees.
?Goal-oriented and focused on meeting deadlines within a highly competitive environment.
?Executing for results: Maintains high standards of performance for himself/herself and others, and follows through on commitments.
?scientific thinking with clear argumentation and ability to reduce complex issues to the main points, self-confidence. Social competence, customer orientation and team player. 举报 分享

关于勃林格殷格翰
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