- Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, and regulatory submission documents
- Perform investigations and technical troubleshooting
- Provide documentation and technical input during regulatory and internal inspections and audits
- Apply working knowledge of data integrity
- Train staff on analytical techniques and problem solving as needed
- Influence external sites in the worldwide manufacturing network to identify, implement, and troubleshoot laboratory test methods, workflows, and materials
- Support compliant, robust, and responsive supply
- Drive lead-time reduction and efficiency gains supporting World Class Supplier and Operationalizing Quality goals
Requirements
- MS in Chemistry or related discipline with at least 5 years of relevant pharmaceutical development experience, or PhD in Analytical Chemistry or related discipline
- Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances
- Strong verbal and written communication skills
- Flexibility to work in a dynamic environment with internal and external communications
- Strong interpersonal skills and cultural sensitivity
- Self-motivated ownership and accountability for issues through completion
- Ability to adapt quickly to changes and develop risk-management plans
- Willingness to travel abroad
- Knowledge of developing analytical techniques such as chromatography and spectroscopy and product specifications for drug substance development and registration
- Fundamental knowledge of synthetic organic chemistry
- Working knowledge of API development and commercialization
- Experience with contract manufacturing organizations and/or contract research organizations
- Experience working in cross-functional teams
- Strong technical background, problem-solving skills, leadership abilities, cGMP knowledge, and data integrity knowledge
Core Competencies
Demonstrates expertise in analytical techniques, including chromatography and spectroscopy, with a strong foundation in synthetic organic chemistry and API development. Proven ability to lead cross-functional teams, ensure compliance with cGMP standards, and effectively communicate technical information.
Highest-signal resume keywords
- Analytical Techniques
- Chromatography
- Spectroscopy
- CGMP Knowledge
- Data Integrity
ATS Optimization Keywords
Hard Skills
- Analytical Procedures
- Validation Protocols
- Technical Reports
- Experimental Designs
- Regulatory Submission Documents
- Problem-Solving
- Risk-Management Plans
- API Development
- Drug Substance Development
- Product Specifications
Soft Skills
- Strong Verbal Communication
- Strong Written Communication
- Interpersonal Skills
- Cultural Sensitivity
- Self-Motivated
Industry Keywords
- Pharmaceutical Development
- Contract Manufacturing Organizations
- Contract Research Organizations
- Cross-Functional Teams
- World Class Supplier