Senior Biotechnology Leader
">
We are seeking a seasoned Biotechnology Expert to lead our team in the development of innovative pharmaceutical products. This is an exciting opportunity for someone who wants to leverage their technical expertise and leadership skills to drive business success.
">
The ideal candidate will have a strong background in biotechnology, including experience with drug substance development, process sciences, and laboratory operations. They should also possess excellent communication and project management skills, as well as the ability to motivate and guide a high-performing team.
">
In this role, you will be responsible for providing technical oversight of biologics inline & pipeline products, leading technical assessments, and coaching the team on development and execution of technical studies. You will also be expected to contribute to the creation of the laboratory budget and review actual performance against forecast.
">
To succeed in this position, you will need to demonstrate a deep understanding of current regulatory requirements and good manufacturing practices. A master's degree in biological sciences or a related field is required, along with at least 8 years of direct experience in academia, pharmaceutical, or biotechnology companies.
">
This is a challenging and rewarding opportunity for someone who is passionate about biotechnology and has a proven track record of delivering projects and programs. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply.
">
Key Responsibilities:
">
• Manage, coach, and mentor the drug substance team in performing advanced technical experiments.
">
• Provide technical oversight of biologics inline & pipeline products.
">
• Lead technical assessments for process investigations, risk assessments, evaluation of specifications and material qualification.
">
• Coach the team on development and execution of technical studies, continuous improvement of existing biologics processes and for new product launch.
">
• Complete experimental design, execution, data analysis and interpretation for improvement programs.
">
• Oversight of product robustness trends observed in commercial operations and alignment with laboratory models, such as multivariate data analyses.
">
• Assist in regulatory authoring and review of technical documentation, technical report writing and global regulatory submissions.
">
• Support creation of the laboratory budget and review actual performance against forecast.
">
Requirements:
">
• Master's in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry.
">
• 8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices.
">
• Strong understanding of lean and laboratory operations.
">
• Excellent communication and project management skills.
">
• Ability to motivate and guide a high-performing team.
"],