Job DescriptionJob Summary:A pharmaceutical manufacturing client is seeking a Senior Scientist to provide critical support within their Method Transfer and Development Group by performing analytical method validation activities (draft protocols/reports, execute validation assays, data analysis), and procedural updates. Additionally, the candidate should be reviewing various reports, and data to in accordance with cGMP and data integrity principles. The candidate should guide the newer resources on the documentation and good manufacturing practices.Responsibilities: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 as necessary.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 when required.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/ .Skills and RequirementsBS+8 years of industry experience, preferably in GMP; MS + 6 years of industry experience, preferably in GMP or PhD. + 2 years of industry experience, preferably in GMP.Extensive hands-on experience and strong background in either Chemistry, Microbiology or molecular biology assays.Experience with troubleshooting assays and improving method performance.Strong technical writing and presentation skills. Experience with method validation and method transfer skills to manufacturing site.Experience with bio-process downstream development.Understanding of critical quality attributes of drug substance and drug product. nullWe 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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
