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Bioprocess Expert Lead
2 weeks ago
We are seeking a highly skilled and experienced professional to make life better for people around the world.
The successful applicant will have technical expertise in downstream bioprocessing and experience in data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and process improvements, maximizing the benefits of a digital plant through data analytics and process analytical technology.
Key Responsibilities:
- Develop in-depth knowledge of downstream cell culture processes and molecule-specific control strategy and basis of specifications and critical attributes.
- Understand the purpose and capability of each downstream unit operation and the impact of equipment on the process.
- Provide technical expertise to support teams for process science, operational excellence, and compliance.
- Work as part of a cross-functional team to bring deep technical expertise and scientific rigor.
- Utilize process monitoring tools to ensure process consistency and robustness.
- Engage with statisticians to assign specifications, validation acceptance criteria, and analysis of batch data.
- Ensure regulatory, compliance, and process monitoring needs are captured in manufacturing documentation.
- Identify process improvements and participate in Lean Manufacturing initiatives.
- Generate scientific reports and technical documentation.
- Ensure safety, compliance, and regulatory expectations.
Attributes for the Role:
- Demonstrated technical capability with high productivity.
- Proven track record of curiosity with learning agility.
- Self-starter with high initiative and data-driven approach to problem-solving.
- Strong interpersonal skills.
- Strong verbal and written communication skills.
- Adaptability and flexibility to working in different environments.
- Ability to participate in and facilitate decision-making.
Educational Requirements:
- Bachelor's, Master's, or PhD qualification in relevant scientific discipline.
- Minimum 5 years' experience in the Biopharmaceutical industry.