Associate Manufacturing Scientist

The Position

This position will involve assisting in the synthesis and subsequent purification steps of large scale oligonucleotides. The operator must comply with GLP/GMP protocols and be able to follow all association SOPs and work instructions when performing and documenting operations.

Responsibilities

• Prepare batch records, SOPs, and work instructions to detail

• Document alloperations in batch records and notebooks

• Experience in investigating and closing deviations

• Ability to identify, design, and implement process improvements

• Comply with GMP protocols

• Operate large scale oligonucleotide manufacturing equipment (i.e. oligonucleotide synthesizer, purification skid, tangential flow filtration system, lyophilizer, ChemGlass reactors, pH/conductivity meters, peristaltic pumps, )

• Lead and provide support to other chemists within the CMC group during synthesis and purification of oligonucleotides including:

• Reagent solution preparation

• Mobile phase preparation

• Column Packing

• Fraction collection

• Develop and optimize test methods for oligonucleotide/intermediate analysis via LCMS

• Assist in scale up/process development from small/mid-scale chemistry

• Contact vendors for purchasing manufacturing equipment/performing routine maintenance and repair, and assist with FATs for equipment as needed

• Maintain a clean work space

• Maintain safety by wearing required personal protective equipment

• Maintain safety by wearing required personal protective equipment

• Track and update raw material usage in D365 ERP software

• Act as production campaign lead

• Assist with new personnel training

• Address and resolve production challenges proactively, utilizing analytical and critical thinking skills

Requirements:

• Bachelors degree in a scientific field
• 5-10 years experience in a similar position
• Experience working in a GMP setting and controlled documentation
• Ability to move and lift up to 50 pounds
• Good verbal and written communication skills
• Ability to work in a team environment
• Ability to pay attention to detail