Senior Manager - (Global Upstream MSAT) - Biotech

Proclinical is seeking a dedicated and skilled professional to join the team as a Senior Manager in Global Upstream MSAT. This role will be a crucial pivotal technical leader, focusing on upstream technologies. The successful candidate's responsibilities will include coordinating technical and laboratory activities to support technology transfer, cGMP manufacturing, and process improvements. As well as, leading cross-functional teams to ensure successful process transfer and lifecycle management.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Coordinate laboratory activities for technology transfer and process improvements.
• Oversee Process Transfer & Sciences SME activities and establish efficient workflows.
• Lead cross-functional project teams for process transfer, validation, and lifecycle management.
• Provide technical manufacturing support, monitor processes, and resolve technical issues.
• Conduct technical investigations, root-cause analyses, and define corrective actions.
• Prepare and evaluate change control documentation.
• Develop technical protocols and reports for process performance qualification and regulatory submissions.
• Analyse and trend process data to enhance process robustness and implement productivity initiatives.
• Communicate updates to stakeholders and leadership, ensuring alignment with strategic objectives.

Key Skills and Requirements:

• Degree in a relevant technical field.
• Extensive experience in manufacturing operations within pharmaceutical or biotech facilities.
• Expertise in cell culture technology and advanced upstream bioprocess technologies.
• Proven project management and people management experience.
• Strong interpersonal skills with the ability to influence and negotiate effectively.
• Proficiency in data analysis, technical writing, presentation, and communication.
• Solid understanding of cGMP, FDA/EMA compliance regulations, and experience with regulatory inspections.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.