Were seeking a highly motivated and team-oriented Manufacturing Chemist with experience in oligonucleotide synthesis and analytical instrument experience to join our Primer Manufacturing group. The candidate must have a strong understanding of purification techniques used in the manufacture of complex nucleotides, such as Ion Exchange and Hydrophobic Interaction Chromatography. The candidate should have at least two years of chemistry bench experience in synthetic processes.
Responsibilities:
• Synthesize complex organic molecules per established protocols • HPLC purification and analytical HPLC instrument setup, sample preparation, run execution and data analysis. • Follow all SOPs and WIs as required by the Quality Management System. Provides input to revise and improve processes. • Plan and execute daily work with minimal supervision. • Generates and analyzes data that leads to decision-making without supervision. • Executes at a consistently high quality across varying complexities and with a broad array of techniques. • Operate in compliance with all appropriate regulatory and safety requirements and apply all relevant protocols to work responsibilities. Aids in creating and revising process risk assessments. • Contributes to investigation and resolution of technical problems. • Completes ERP transactions for manufacturing work order processing. Can analyze variances, understand, and modify routings, and assess part number set up. • Trains new personnel on production tasks, including the scientific concepts underpinning the tasks. • Aids in catch activities for Manufacturing for new products, insourcing, etc. • Work with cross-site and cross-functional teams in R&D, EH&S, Quality Assurance, and Manufacturing Engineering. • Collaborate with cross-functional teams to assess safety and quality risks and drive improvements where appropriate. • Perform safety and quality inspections through an established 6S program. • Operate equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
• At least 2 years of experience in synthetic chemistry processes, purification, and QC analysis of organic molecules. • Demonstrated ability to follow established protocols in the production of complex organic molecules. • Solid technical knowledge of synthetic organic chemistry, HPLC methods, manufacturing processes, and manufacturing execution systems. • High level knowledge with standard laboratory equipment (HPLCs/UPLCs, synthesizers, reactors, rotary evaporators, UV/Vis spectrophotometers, pH meters, etc.). • Excellent written and verbal communication skills required. • Basic understanding of equipment/instrument upkeep, calibration, and maintenance policies. • Familiar with ISO 9001, 13485 and FDA QSR manufacturing standards. • High level knowledge with ERP, EAM, MES and Quality systems (SAP, Camstar, Teamcenter, etc.). • Basic knowledge of life science industry and experience in DNA analysis methods preferred. • Experience in lean manufacturing and continuous improvement methodologies preferred. • High level knowledge of Microsoft Office (Excel, Word, etc.) • Ability to carry up to 40 lbs. • Bachelor's degree in Biology, Biochemistry or Chemistry, with specialization in synthetic or analytical chemistry preferred.