What are the responsibilities and job description for the Downstream Process Scientist position at Astrix?

Our client, a renowned global leader in both R&D and manufacturing within the biopharma industry, is seeking an experienced Downstream Manufacturing Scientist to join their dynamic team. This opportunity will allow you to continue your career in biopharmaceutical manufacturing while contributing to the success of cutting-edge projects across a global footprint.

This is an exciting opportunity to advance your career in the biopharmaceutical industry with a globally recognized leader in R&D and manufacturing. You’ll play a pivotal role in shaping the future of biopharmaceutical production, working on innovative processes that have a direct impact on improving patient outcomes.

Essential Duties & Responsibilities :

Perform downstream processing in a cGMP environment, including tasks such as column packing, troubleshooting processes, and analyzing data.
Provide technical support in the development and execution of purification processes to ensure consistent, high-quality results.
Utilize operational systems to monitor and analyze data, making real-time adjustments to products, equipment, or processes as needed.
Ensure timely execution of engineering and clinical batches while maintaining high standards of quality and compliance.
Develop and refine equipment operating specifications and manufacturing techniques to optimize efficiency and product quality.
Collaborate with both internal teams and external vendors to resolve technical challenges and ensure smooth operation of production equipment.
Adhere to GMP guidelines and lead initiatives to ensure a safe, compliant manufacturing environment that aligns with environmental health and safety standards.
Manage investigations and corrective actions related to batch issues, ensuring timely resolution.
Take on additional tasks as needed, demonstrating adaptability and a flexible approach to project needs.
Ensure full compliance with company policies, operational standards, and quality assurance protocols.

Requirements :

Education and Experience :

Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences.

4-5 years of relevant experience in the biopharmaceutical industry, with a focus on downstream or upstream manufacturing.

Strong background working in GMP and aseptic manufacturing environments.

Proficient in using systems like AKTA Process skids (or similar) and familiar with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.

Experienced in executing engineering and clinical batches, with a solid understanding of GMP documentation practices.

Special Skills :

Strong ability to collaborate with team members and work independently to meet project goals.

Excellent interpersonal skills with effective verbal and written communication abilities.

Exceptional organizational skills and attention to detail.

Proficient in basic computer software, including Microsoft Word, Excel, and spreadsheets.

Expertise in GMP batch manufacturing and packaging documentation, including auditing and review processes.

Familiar with cleaning verification and validation processes in a manufacturing environment.

Apply now to be part of a world-class team dedicated to advancing science and manufacturing excellence in the biopharma industry.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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Downstream Process Scientist

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