Job Description
Responsibilities
• The Scientist will support the Quality Control Method Transfer and Validation team by performing method validation activities including drafting protocols and reports, executing validation assays, and conducting data analysis
• This role also involves procedural updates, reviewing various reports, and ensuring compliance with cGMP and data integrity principles
• Independently conceptualize, plan, and execute laboratory experiments
• Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools
• Lead and manage multiple projects, assisting teams in developing effective strategies for analytical needs and controls
• Engage with the method development team and participate in both in-process and final product sample analyses
• Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes
• Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required
• Independently analyze experimental data and provide conclusive insights
• Mentor junior scientists and offer technical guidance
• The position follows a 1st shift schedule from Monday to Friday, 8 AM to 5 PM, with occasional weekend work on a rotating basis
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
- 7-8 years of experience
- ability to troubleshoot laboratory assays, perform data review, and author protocols, reports, and deviation documents
- Skilled in bioburden, endotoxin testing, culture purity and sterility testing.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.