Todd Outwin
Pharmaceutical Quality Operations Manager, External Manufacturing
- Role
- Quality Manager External Manufacturing at Bristol Myers Squibb
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Todd Outwin
Pharmaceutical professional with a strong process development and analytical background, as well as a proven track record in new systems introduction, seeking role supporting compliant computer systems in the Life Science industry.• In-depth experience with Software Development Life-Cycle Management and established subject matter expert in equipment/instrument qualification, Computer System Validation, Good Manufacturing Practices and 21 CFR Part 11 compliance.• Implement and provide technical support for wide range of pharma processes and information management systems in current good manufacturing practice (cGMP) production areas through instituting interdepartmental project plan, managing multiple projects, overseeing qualification / test script execution, and training user department personnel on new systems.• Successfully resolved various quality issues during equipment qualification and computer validation test script execution.• Document and communicate technical information clearly and concisely for internal management, external vendors, contractors and user department personnel by authoring qualification protocols and reports, traceability matrices, standard operating procedures (SOP), requirement specifications (URS/SRS), and other.
Experience
Quality Manager External Manufacturing
May 2022 — Present · NJ, US
Education
Albright College
BS, Psych-Bio
1992 — 1997
Mercer County Community College
Certification, Drug Development & Clinical Research
1999 — 2001
Skills
- Formulation
- Quality Assurance
- Nir Spectroscopy
- Laboratory
- Drug Development
- Solid Oral Dosage Forms
- Process Automation
- Glp
- Wet Chemistry
- Process Analytical Technology
- Hplc
- Chemometrics
- R&D
- Technical Writing
- Clinical Trials
- Pharmaceutical Industry
- Drug Delivery
- Gas Chromatography
- Process Analysis
- Product Development
- Process Control
- Qualification Testing
- Design of Experiments
- Pharmaceutics
- Sop Authoring
- Analytical Chemistry
- Validation
- Quality Control
- Gmp
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