Biochemical Analyst

Salary: Negotiable

We are seeking a highly skilled Analyst to join our biotechnological production site focused on therapeutic proteins. This role involves performing, developing, and implementing advanced analytical technologies to support existing and new production processes. The primary responsibilities include conducting analytical experiments, supporting method development and validation, and ensuring the quality and reliability of analytical methods.

Analytical Experimentation:

• Execute a variety of analytical experiments to support quality control, product characterization, and additional research.
• Ensure the accuracy and reliability of experimental results through meticulous data trending and monitoring.

Method Development and Validation:

• Assist in designing, developing, improving, and validating existing analytical methods.
• Implement new analytical technologies to enhance production processes.

Documentation and Reporting:

• Generate analytical reports, scientific and technical study protocols, and reports.
• Maintain, update, and communicate documentation and knowledge.
• Critically analyze data and draw scientifically sound conclusions.

Compliance and Safety:

• Adhere to all applicable quality and safety standards, including cGMP requirements.
• Apply policies related to employee well-being, environmental care, and energy management.
• Report incidents and non-conformities and assist in identifying risks and preventive measures.

Educational Background:

• Bachelor's or Master's degree in Life Sciences (e.g., biotechnology, biochemistry, pharmaceutical sciences) or equivalent experience.

Technical Skills:

• Proficiency in HPLC/UPLC based assays (e.g., size exclusion, anion exchange).
• Excellent technical writing skills for protocol and report development.

Experience:

• Proven experience in executing analytical experiments.
• Experience with method development and validation in a biotechnological or pharmaceutical setting.

Problem-Solving Abilities:

• Strong problem-solving skills and the ability to manage multiple tasks simultaneously.

Data Analysis:

• Ability to critically analyze data and formulate scientifically sound conclusions.

Regulatory Knowledge:

• In-depth understanding of cGMP and ability to translate regulatory requirements into effective action plans.

Communication Skills:

• Strong communication skills, both written and verbal, in English.

Personal Attributes:

• Detail-oriented, result-driven, and capable of independent planning.
• Flexible, stress-resistant, and open to change and innovation.
• Team player with excellent interpersonal skills.

The role is primarily performed in a non-GMP environment with regular check-ins in cGMP settings. It requires adherence to all quality and safety standards set by regulatory bodies. The position involves working within a cultural framework that values quality, safety, and effective product delivery.

This position offers the opportunity to contribute to the production of high-quality, safe, and effective therapeutic proteins, ensuring compliance with all applicable standards and regulations.