at Randstad US in waukegan, Illinois, United States
Job Description
sr scientist, method development and validation.
+ waukegan , illinois
+ posted july 23, 2024
job details
summary
+ $90,000 – $120,000 per year
+ permanent
+ bachelor degree
+ category life, physical, and social science occupations
+ reference48528
job details
job summary:
Randstad is the #1 HR Services Company in the world and we are sourcing for a Sr. Scientist of Method Development and Validation in the Northern Suburbs of Chicago, IL. This 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. This is a direct hire position and can start immediately.
location: Waukegan, Illinois
job type: Permanent
salary: $90,000 – 120,000 per year
work hours: 9 to 5
education: Bachelors
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:
+ BS or MS degree in chemistry or biology or related field
+ 4+ years of experience in a GMP analytical laboratory.
+ Method development and validation experience.
+ Accurate documentation and observation skills
+ Strong analytical laboratory skills including all relevant pharmaceutical QC techniques
+ Ability to exercise independent intellectual judgment based on their specialized skills in the field of science
+ Technical project leadership abilities, including good written and verbal communication skills
+ Able to train others
+ Working knowledge of the cGMP regulations
+ Working knowledge of safe handling practices of dangerous chemicals
+ Computer 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: HPLC, Assay Development, Assay Method, Biology, Chemistry, GMP (Good Manufacturing 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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
