at Randstad US in waukegan, Illinois, United States
Job Description
sr scientist ii-mdv.
+ waukegan , illinois
+ posted january 3, 2023
job details
summary
+ $110,000 – $120,000 per year
+ permanent
+ postgraduate degree
+ category life, physical, and social science occupations
+ reference44268
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: $110,000 – 120,000 per year
work hours: 9 to 5
education: Masters
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:
QUALIFICATIONS
+ BS / MS or Ph.D. degree in chemistry or biology or related field
+ The candidate will possess an emphasis in ICP-MS development supporting ICH-Q3D requirements for the development and validation of methods supporting trace element analysis at low ppb / ppt levels. Demonstration of development for a wide range of product structural classes would be a plus.
+ In addition, the candidate could have demonstrated proficiency in HPLC, GC, LC-MS, GC-MS and other common analytical instrumentation and wet chemical techniques supporting API and excipient product development.
+ 7+ years of experience in a GMP analytical laboratory. Method development and validation experience is required.
+ 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 ICP-MS (required) and experience with other analytical instrumentation. (HPLC and GC with Empower, HPLC-MS, GS-MS) would be preferred.
+ Experience with carbohydrate, amino acids, lipids and/or small molecule APIs is desirable
+ Experience working in a CDMO environment is desirable.
Physical Requirements
+ Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant.
+ Must be able to sit and/or stand for extended periods.
+ Ability to work effectively under pressure to meet deadlines
+ Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
+ Must be able to lift 25 lbs. or occasionally lift up to 35 lbs.
+ Ability to wear proper safety equipment when working in the laboratory or plant
skills: Quality control, SOP, Quality Assurance, Data Analysis, ADME, Analytical Chemistry, Assay Development, Assay Method, Assay Verification, Biology, Chemistry, GLP (Good Laboratory Practice), CDISC, Data Validation Plan, Statistical Analysis Plan, Statistical Programming, Biostatistical Analysis, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad’s client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
