The Senior Analytical Scientist performs complex laboratory analyses of pharmaceutical and biopharmaceutical products. The role involves the use of advanced analytical instrumentation, data analysis, and ensuring compliance with PPD SOPs and industry regulations. This position often serves as the project leader, managing multiple projects, interacting with clients, and ensuring the scientific integrity of data. The Senior Analytical Scientist is responsible for conducting method validations, method transfers, and analytical testing, mentoring team members, and assisting in troubleshooting instrumentation and analytical challenges.
Key Responsibilities:
- Independently performs method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds across various formulations and delivery systems.
- Conforms to established methods and protocols for assigned tasks, designing and executing experiments with minimal supervision.
- Prepares study protocols, project status reports, final study reports, and other project-related technical documentation.
- Communicates data and technical issues to clients, responding promptly to their needs and inquiries.
- Mentors, trains, and coordinates laboratory activities of junior team members while assisting in troubleshooting instruments and analytical problems.
- Participates in quality systems, assists in new equipment introductions, and provides feedback on improvements.
- Designs method validation and transfer protocols and works on establishing realistic project timelines.
- Reviews, interprets, and analyzes data for technical accuracy, quality, and compliance with project specifications, SOPs, and applicable industry regulations (GMP/GLP).
- Conducts self and peer reviews to ensure data accuracy and compliance before submission to Quality Assurance (QA) and subsequent issuance to clients.
- Acts as the primary point of contact for project teams, interacting with internal and external personnel to ensure effective coordination across functional areas.
- Maintains up-to-date knowledge of industry trends, regulatory guidelines, and technological advancements.
Required Knowledge & Skills:
- Expert knowledge in laboratory analytical techniques and instrumentation, including HPLC, GC, UV-Vis, FTIR, and other common methods used in pharmaceutical testing.
- Experience in method validation, method transfer, and data interpretation.
- Strong ability to analyze complex data sets and resolve scientific and technical issues.
- Knowledge of regulatory requirements, including GMP, GLP, and other applicable standards.
- Ability to work independently with minimal supervision while coordinating efforts with internal and external stakeholders.
- Proven track record of mentoring and leading teams in a laboratory setting.
- Proficiency with common laboratory software and tools, as well as data analysis programs.
Qualifications:
- Education: Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Advanced degree preferred.
- Experience: 5+ years of relevant experience in pharmaceutical or biopharmaceutical laboratory settings.
- Certifications: Relevant certifications in laboratory practices and quality systems (e.g., GMP, GLP) are a plus.
Work Environment:
- Primarily office and laboratory-based work, with occasional fieldwork or client site visits.
- Physical demands may include standing for long periods, handling chemicals, and operating laboratory equipment.