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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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Lori Steiner's Top 3 Jobs

Science & Biotech - Durham, NC 27710

Will support formulation development work by developing, troubleshooting, and validating suitable analytical (LC, GC) test methods quickly and efficiently. Examples include assay and related subs methods for actives, fast LC methods for DDU and APSD, and GC and LC methods for excipients. Will perform hands-on lab work as well as direct, develop and train analytical scientists. Will provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry, manufacturing and controls (CMC). In addition, will trans...

View Sr. Manager, Inhalation Job - Durham, NC 27710
Science & Biotech - Durham, NC 27710

Senior Regulatory Specialist is responsible for coordinating the registrations of products in US and/or international markets. Description Plan, compile, prepare, and submit applications (510(k), PMA, Technical Documentation, etc.) to register new, and re-register existing, company products with foreign regulatory agencies. Communicate with FDA and other regulatory bodies regarding submissions. Review and approve changes for design, manufacturing and labeling changes to ensure compliance with FDA and international government regulations. Own de...

View Sr. Regulatory Affairs Specialist - Medical Device Job - Durham, NC 27710
medical device, pma, 510k, international, submission
Science & Biotech - Durham, NC 27710

Responsibilities and Accountabilities • Demonstrates innovative design, development, and execution of process development projects through literature review and scientific teamwork. • Assess and interpret experimental data using DOE and statistical techniques. • Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors. • Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing and sup...

View Sr. Scientist, Upstream Process Development, Gene Therapy Job - Durham, NC 27710