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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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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
Science & Biotech - Durham, NC 27707

Responsibilities: • Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage • Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials • Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific...

View Director, Medical Monitoring - Remote Job - Durham, NC 27707
Science & Biotech - Durham, NC 27710

Description: Candidate will be responsible for actively developing new pharma and biotech business to drive new revenue growth in the U.S. Responsibilities include but not limited to acquiring new business and developing relationships through individual’s pre-existing contacts, and may possibly include taking over existing client work. Candidate must be technically independent much of the time, be well experienced in compiling and writing RFP proposals, working in depth with internal core teams and clients for successful technical transfers, have a s...

View Sr. Director Business Development - Remote Job - Durham, NC 27710
CDMO, CMC Manufacturing,
Science & Biotech - Durham, NC 27703

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

View SAS Programmer - Remote! Job - Durham, NC 27703
Science & Biotech - Durham, NC 27707

The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up,maintenance, and completion activities and develop [Global]Data Management Plans and Quality Management (QM) plans that will deliver accurate, timely, consistent, and quality clinical data. Additional responsibilities include: • Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development ...

View Lead Clinical Data Manager - REMOTE! Job - Durham, NC 27707