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Manufacturing Scientist Associate
2 months ago
Arrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies that target genetic diseases through RNA interference. Our mission is to create effective treatments for conditions caused by the overproduction of specific proteins, utilizing advanced RNAi technologies.
Role Summary
The Associate Manufacturing Scientist will play a crucial role in the synthesis and purification of large-scale oligonucleotides. This position requires strict adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring compliance with all standard operating procedures (SOPs) and work instructions during operations.
Key Responsibilities
- Prepare and maintain detailed batch records, SOPs, and work instructions.
- Accurately document all operations in batch records and laboratory notebooks.
- Investigate and resolve deviations effectively.
- Identify, design, and implement enhancements to manufacturing processes.
- Ensure compliance with GMP protocols throughout all activities.
- Operate large-scale oligonucleotide manufacturing equipment, including synthesizers and purification systems.
- Support fellow chemists in the CMC group during oligonucleotide synthesis and purification processes, including:
- Preparation of reagent solutions.
- Preparation of mobile phases.
- Column packing and fraction collection.
- Develop and optimize analytical methods for oligonucleotide and intermediate analysis using LCMS.
- Assist in scaling up and developing processes from small to mid-scale chemistry.
- Coordinate with vendors for the procurement of manufacturing equipment and assist with routine maintenance and repairs.
- Maintain a clean and organized workspace, adhering to safety protocols by wearing appropriate personal protective equipment.
Qualifications
- Bachelor's degree in a relevant scientific discipline.
- 5-10 years of experience in a similar manufacturing role.
- Proven experience in a GMP environment with controlled documentation practices.
- Physical capability to lift and move up to 50 pounds.
- Strong verbal and written communication skills.
- Ability to work collaboratively within a team setting.
- Attention to detail and a commitment to quality.
Arrowhead Pharmaceuticals offers competitive salaries and a comprehensive benefits package.
