job summary:Individual will independently design, develop and validate analytical methods while acting as analytical lead for multiple projects. Provide analytical support for research, development, and manufacturing activities. Additionally, this position will support other activities associated with laboratory operation and will review data for compliance, review policy and procedure documents as necessary to meet cGMP regulations and applicable guidelines. Perform training of other scientists on complex and/or specialized analytical techniques. Act as a resource for instrument troubleshooting and guidance to other scientists. Must be able to work in a complex, fast paced environment. location: Waukegan, Illinoisjob type: Permanentsalary: $70,000 - 85,000 per yearwork hours: 9 to 5education: Bachelors responsibilities:ESSENTIAL DUTIES AND RESPONSIBILITIES Develop and validation of analytical methods in compliance with ICH guidelines for novel API and excipient products under the guidance of analytical project leader.Develop and execution of study plans to assess feasibility of client provided method including development and execution of method validation and implementation.Act as project analytical lead. Perform oversight of all methods related to a project, coordination of implementation of methods, support for implementation of IP/PBR/specifications and communications with project management.Provide project support through testing requests, compilation and assessment of data, feedback on analysis approach and reporting of findings to supervisor and / or project lead including issues/abnormal observations while striving to adhere to assigned due dates.Perform review of existing validations against current standards, generation of gap assessment report and remediation plan to close validation gaps.Perform technical and compliance review of complex analytical tests while ensuring scientific integrity.Execution of testing protocols without deviation.Willingness to work on Safebridge Category I-III compounds.Perform training of other scientists on complex and/or specialized analytical techniques.Requires full understanding of multiple instruments/methodologies including functionality and the ability to troubleshoot issues.Authoring of templated technical documents.Maintain analytical equipment (periodic calibration and maintenance) in accordance with PI policies and procedures.Maintain files as directed.Perform data entry into spreadsheets and proprietary computer systems.Operate following policies and procedures to meet cGMP regulations and ICH guidelines.Maintain documentation in an accurate, clear and concise manner in accordance to company policies and procedures. Maintain a clean, safe and orderly workplace, following all applicable EHS policies and procedures. qualifications:QUALIFICATIONSBS or MS degree in chemistry or biology or related field4+ years of experience in a GMP analytical laboratory. Method development and validation experience is preferred.Accurate documentation and observation skillsStrong analytical laboratory skills including all relevant pharmaceutical QC techniquesAbility to exercise independent intellectual judgment based on their specialized skills in the field of scienceTechnical project leadership abilities, including good written and verbal communication skillsAble to train othersWorking knowledge of the cGMP regulationsWorking knowledge of safe handling practices of dangerous chemicalsComputer skills (spreadsheet, database and word processing window based programs)Hands-on experience with the operation and maintenance of analytical instrumentation preferred. (HPLC and/or GC with Empower, ICP-MS, HPLC-MS, GS-MS)Experience with carbohydrate, amino acids, lipids and/or small molecule APIs is desirable skills: GLP (Good Laboratory Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.