Job Title: Manufacturing Sciences Upstream Process Technology Lead
Company: International Life Sciences - Solutions de recrutement
About the Role
We are seeking a highly experienced technical expert to join our Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site as a Manufacturing Sciences Upstream Process Technology Lead.
This key leadership role oversees all USP Process Transfer & Sciences activities, leading cross-functional teams to facilitate new product introduction, process transfers, validation and advance process technologies.
Main Responsibilities
* Technical Leadership: Provide guidance and coordination of technical and laboratory activities in support of technology transfer, continued cGMP manufacturing & process improvements.
* USP Process Transfer & Sciences SME Activities: Establish efficient workflows for GMS lab operations & studies.
* Cross-Functional Project Teams: Lead project teams to enable process transfer, validation & process life cycle activities.
* Technical Manufacturing Support: Accountable for technical manufacturing support through process monitoring, resolution of technical issues & participation in operations governance huddles.
* Process Investigations: Lead technical process investigations, root-cause analysis and definition of appropriate corrective measures & effectiveness checks.
* Document Authorship: Author technical protocols/reports for process performance qualification, continued process verification, investigations, and regulatory submissions.
* Process Advancements: Trends & analyses process data to guide & implement advancements of USP process technologies, process robustness & productivity initiatives.
Requirements
* Educational Qualification: Degree in relevant technical discipline. Bachelor's degree plus 10 years of relevant experience, Master's degree plus 8 years of relevant experience or PhD plus 4 years of relevant experience.
* Technical Experience: Excellent technical experience with state-of-the-art upstream bioprocess technologies (incl. PAT) & manufacturing operations.
* Project Management: Proven project management experience and capability to work effectively in a team environment.
* Interpersonal Skills: Good interpersonal skills, with the ability to influence behaviours, negotiate, and resolve challenges with poise, tact, and diplomacy.
* Data Analysis & Communication: Strong data analysis, technical writing, presentation and communication skills.
* cGMP & FDA/EMA Compliance: Practical knowledge and application of cGMP and FDA/EMA compliance regulations and inspections, with experience interfacing with inspectors and/or agency personnel.
This is an exciting opportunity for a highly experienced technical expert to lead projects with cross-functional teams and drive process improvements in upstream drug substance manufacturing operations and process sciences.