Principal Analytical Chemist

SUMMARY

Performs and leads analytical research and development activities for the purpose of designing/improving a manufacturing process or technology as well as producing clinical trial batches by performing the following duties.

Include the following. Other duties may be assigned.

• Leads large and/or multiple teams to accomplish technology transfers and/or development projects.
• Applies analytical and organic chemistry skills to the improvement of processes.
• Responsible for participating in the budget process of research projects and/or technology transfers.
• Initiates and executes the development of new and innovative analytical chemistry and methodology. Provides written analytical procedures and reports to support manufacturing and regulatory needs. Lead analytical technology transfer activities associated with a method or project.
• Develops a comprehensive understanding of internal, corporate, and ICH stability guidelines to provide support to the Corden Stability Program
• Develops and applies analytical techniques at a process scale (e.g., process chromatography)
• Responsible for the analytical sections of process procedures
• Develops key technologies and transfer strategies that function well in a manufacturing environment.
• Plans and formulates aspects of analytical research and development proposals such as objectives or purpose of project, applications that can be utilized from findings, cost of project, equipment, and human resource requirements.
• Identifies analysis points and develops methods, and procedures for monitoring projects. Devises and completes method validation studies.
• Practices excellence in verbal and written communication skills to update management and clients on the current statuses of each project. Maintains documentation such as analysis data and procedures and progress reports in accordance with GLP and company policies.
• Submits patents, presents at scientific conferences and company
  -wide forums, and publishes in scientific journals.
• Investigates new analytical technologies and equipment with the aim of practical utilization in new and existing manufacturing processes.
• Develops expertise in key advanced analytical techniques.
• Analyzes batches of drug substance intermediates and raw materials to be used in clinical registration program.
• Proposes analytical specifications for control of raw materials, intermediates, in-process testing, and drug substances for in-house use and regulatory filings.
• Participates in manufacturing site activities, such as troubleshooting and analytical problem solving.
• Develops thorough understanding of QEH&S principles and regulatory affairs. Impacts analytical process development in at least two areas.
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste.

Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. Leads team in the development, troubleshooting, transfer, and improvement of chemical processes. Expected to work interactively and collaboratively in a project team environment both internally and with clients.

Carries out leadership responsibilities in accordance with Corden policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraise performance, reward and discipline employees; address complaints and resolve problems.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Doctoral degree (PhD) in Chemistry plus 3 years’ experience; or lower degree with 7 years related experience; or equivalent combination of education and experience.

Ability to read, analyze, and interpret common scientific and analytical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, clients, public groups, and/or boards of directors.

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and…