Kimberley Parker
Regulatory Medical Writer | Process Development Engineer | Project Manager
- Role
- Medical Writer and Consultant at Whitsell Innovations, Inc
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Kimberley Parker
PhD Chemical Engineer with biotech/chemical R&D, manufacturing, and project management experience in multifunctional and global team environments. Technical proficiency in process development, scale-up, and tech transfer related to fermentation, cell culture, fine chemical synthesis, biocatalysis, and purification of small molecules and proteins. Strong scientific communicator with technical writing experience including regulatory submissions, scientific journal articles, manufacturing campaign reports, batch production records, SOPs, and URS/TRS documents. Applications include biopharmaceuticals, industrial biotechnology, and crop protection. Trained in Six Sigma methodologies and statistical data analysis. Knowledge of FDA, ICH, cGMP, and EPA regulations.Specialties: Project Management (PMP Certified), Process Development, Scale-up, Tech Transfer, Technical Writing, Six Sigma Black Belt
Experience
Medical Writer and Consultant
Apr 2024 — Present
Education
North Carolina State University
PhD, Chemical Engineering
1997 — 2000
North Carolina State University
MS, Chemical Engineering
1994 — 1997
North Carolina Agricultural and Technical State University
BS, Chemical Engineering
1990 — 1994
Skills
- Minitab
- Formulation
- Ms Project
- Protein Chemistry
- Chromatography
- Sop
- Fda
- Dmaic
- Regulatory Submissions
- Process Improvement
- Pmp
- Herbicides
- Biopharmaceuticals
- Downstream Processing
- Project Planning
- Data Analysis
- Six Sigma
- Gmp
- Glp
- Microsoft Project
- Pilot Plant
- Agrochemicals
- V&V
- Process Simulation
- Fermentation
- Jmp
- Scale-Up
- Biotechnology
- Purification
- Cross-Functional Team Leadership
- Enzyme Technology
- Supervisory Experience
- Centrifugation
- Validation
- Design of Experiments
- Technology Transfer
- Process Control
- Project Management
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