Sr. Scientist - Pharma Analytical Method Development

Apcegen is looking for Sr. Scientist - Pharma Analytical Method Development to join our dynamic team and embark on a rewarding career journey

• Method Development: Designing and developing analytical methods (such as HPLC, GC, spectroscopy, etc) for the analysis of drug substances, drug products, and related compounds
• Method Validation and Optimization: Validating and optimizing analytical methods to ensure accuracy, precision, specificity, linearity, and robustness in compliance with regulatory guidelines
• Instrumentation Expertise: Utilizing and maintaining sophisticated analytical instrumentation and equipment required for method development and validation
• Data Analysis and Interpretation: Analyzing and interpreting experimental data, ensuring data integrity, and preparing comprehensive reports and documentation
• Regulatory Compliance: Ensuring adherence to regulatory standards (such as FDA, ICH) and industry guidelines in all analytical method development activities
• Project Management: Managing projects, timelines, and collaborating with cross-functional teams for successful completion of analytical method development initiatives

Qualifications:

• Education: A PhD or master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field, coupled with relevant experience in analytical method development
• Experience: Substantial experience (typically 5+ years) in pharmaceutical analytical method development within the pharmaceutical or biopharmaceutical industry
• Technical Skills: Proficiency in various analytical techniques (HPLC, GC, spectroscopy, etc), method validation, statistical analysis, and instrumental analysis

Key Attributes:

• Problem-Solving Abilities: Capability to troubleshoot analytical challenges, optimize methods, and implement innovative solutions for complex analytical problems
• Attention to Detail: Meticulousness in conducting experiments, analyzing data, and maintaining accurate records in accordance with regulatory standards
• Regulatory Knowledge: Comprehensive understanding of regulatory requirements and guidelines governing pharmaceutical analytical method development and validation
• Communication and Collaboration: Excellent communication skills to effectively convey scientific concepts, collaborate with multidisciplinary teams, and present findings