The Analytical Development-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies.
Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.
location: North Chicago, Illinois
job type: Contract
salary: $25 - 30 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Laboratory operational support for the group's experimental development and testing activities
- Complex solution preparation in a GxP environment
- Laboratory balance checks and pH meter standardizations
- Inventory/resource management (e.g. ordering supplies, stockkeeping, etc.)
- Laboratory hygiene including waste disposal management and safety checks
- Document experimental data appropriately in an electronic laboratory notebook
- Problem solving, either independently or with assistance, pertaining to experiment and/or instrumentation issues
- Identify areas for improvement in laboratory operations to improve efficiency and resource usage and assist in continuous improvement activities
- Understand and adhere to Company corporate standards regarding code of conduct, safety, policies and procedures, and GxP compliance
qualifications:
Required Qualifications
- BS in scientific discipline (e.g. Chemistry, Biochemistry, or Biology) with previous laboratory experience
- Experience in Microsoft Office (Excel, Power Point, and Word)
- Experience with bioanalytical techniques
- Document experimental data appropriately in an electronic laboratory notebook within a GxP environment
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Biology, Chemistry, GLP (Good Laboratory Practice), 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.
