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Process Sciences Operations Manager
vor 2 Wochen
Company Overview: At Recrutis, we are dedicated to delivering innovative solutions in Life Sciences recruitment. We strive to match talented professionals with exciting opportunities that drive growth and success.
Job Description: As a key leader in Upstream Process Technologies, you will join our client's Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site. Your primary responsibility will be to oversee all USP Process Transfer & Sciences activities.
Main Tasks:
- Provide technical leadership in USP process technologies, ensuring coordination of technical and laboratory activities in support of technology transfer, continued cGMP manufacturing, and process improvements.
- Offer guidance and coordinate USP Process Transfer & Sciences SME activities, including GMS lab operations and studies. Establish efficient workflows.
- Lead cross-functional project teams to enable process transfer, validation, and process life cycle activities.
- Ensure technical manufacturing support through process monitoring, resolution of technical issues, and participation in operations governance huddles.
- Investigate technical process issues, perform root-cause analysis, and define corrective measures and effectiveness checks. Author and assess change controls.
- Develop and review technical protocols/reports for process performance qualification, continued process verification, investigations, and regulatory submissions.
- Analyze process data to guide advancements of USP process technologies, process robustness, and productivity initiatives.
Requirements:
- Educational Qualification: Degree in a relevant technical discipline.
- Proven technical experience with state-of-the-art upstream bioprocess technologies (including PAT) and manufacturing operations.
- Strong project management skills and ability to work effectively in a team environment.
- Excellent interpersonal skills, with the ability to influence behaviors, negotiate, and resolve challenges with poise, tact, and diplomacy.
- Strong data analysis, technical writing, presentation, and communication skills.
- Practical knowledge and application of cGMP and FDA/EMA compliance regulations and inspections, with experience interfacing with inspectors and/or agency personnel.
