<p>The Position</p> <p>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. This is a 3rd shift position, working four 10-hour shifts Monday - Thursday. This role is eligible for a 15% shift differential.</p> <p>Responsibilities</p> <ul> <li> <p>Prepare batch records, SOPs, and work instructions to detail</p> </li><li> <p>Document all operations in batch records and notebooks</p> </li><li> <p>Experience in investigating and closing deviations</p> </li><li> <p>Ability to identify, design, and implement process improvements</p> </li><li> <p>Comply with GMP protocols</p> </li><li> <p>Operate large scale oligonucleotide manufacturing equipment (i.e. oligonucleotide synthesizer, purification skid, tangential flow filtration system, lyophilizer, ChemGlass reactors, pH/conductivity meters, peristaltic pumps, )</p> </li><li> <p>Lead and provide support to other chemists within the CMC group during synthesis and purification of oligonucleotides including:</p> </li><li> <p>Reagent solution preparation</p> </li><li> <p>Mobile phase preparation</p> </li><li> <p>Column Packing</p> </li><li> <p>Fraction collection</p> </li><li> <p>Develop and optimize test methods for oligonucleotide/intermediate analysis via LCMS</p> </li><li> <p>Assist in scale up/process development from small/mid-scale chemistry</p> </li><li> <p>Contact vendors for purchasing manufacturing equipment/performing routine maintenance and repair, and assist with FATs for equipment as needed</p> </li><li> <p>Maintain a clean work space</p> </li><li> <p>Maintain safety by wearing required personal protective equipment</p> </li><li> <p>Maintain safety by wearing required personal protective equipment</p> </li><li> <p>Track and update raw material usage in D365 ERP software</p> </li><li> <p>Act as production campaign lead</p> </li><li> <p>Assist with new personnel training</p> </li><li> <p>Address and resolve production challenges proactively, utilizing analytical and critical thinking skills</p> </li></ul> <p>Requirements:</p> <ul> <li>Bachelors degree in a scientific field </li><li>5-10 years experience in a similar position </li><li>Experience working in a GMP setting and controlled documentation </li><li>Ability to move and lift up to 50 pounds </li><li>Good verbal and written communication skills </li><li>Ability to work in a team environment </li><li>Ability to pay attention to detail </li></ul>