Manager of Manufacturing Science and Technology
2 weeks ago
Job Description:
We are seeking a highly skilled Manager of Manufacturing Science and Technology to join our team at Recruitment by Aphex Group.
About the Role:
- Lead technical assessments for process investigations, risk assessments, evaluation of specifications, and material qualification.
- Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments.
- Develop and execute technical studies, continuous improvement of existing biologics processes, and new product launch.
- Complete experimental design, execution, data analysis, and interpretation for improvement programs.
Responsibilities:
- Oversee the product robustness trends observed in commercial operations and alignment with laboratory models.
- Leverage digital tools to deliver business value through predictive/proactive issue resolution and rapid investigation closure.
- Assist in the regulatory authoring and review of technical documentation and global regulatory submissions.
Requirements:
- Masters degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry.
- 8+ years directly related working knowledge in academia, pharmaceutical, or biotechnology company.
- Familiarity with current regulatory requirements and Good Manufacturing Practices.
- Demonstrated ability to deliver projects and programs, with a strong understanding of lean and laboratory operations.
- Excellent oral and written communication skills.
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