Job Title: Senior Analytical Chemist
The Senior Analytical Chemist conducts research, analysis and experimentation on substances for such purposes as product and process development and application, quantitative and qualitative analysis, and improvement of analytical methodologies. He/She also maintains the laboratory and all documentation within GLP/cGMP guidelines. The Senior Analytical Chemist performs complex activities and applies basic understanding of scientific data/ literature in areas related to Analytical Services. He/she is expected to present ideas for modifying existing procedures and suggest alternative methods for improving results and provide solutions to a variety of problems.
- Apply basic scientific principles and techniques to complete assigned complex experimental activities related to the endeavors of Analytical Services and receive limited supervision on specified tasks.
- Develop and validate test methods.
- Perform routine and non-routine analysis on raw materials, drug substances, reference material and drug products using a variety of instrumental and wet chemistry techniques. - Recognize the necessity for independent literature reading and scans literature in the area of responsibility.
- Solve technical problems within the scope of the assignment with assistance from supervisor. Show ingenuity in resolving problems.
- Submit progress reports as appropriate and assists in the preparation of study reports in a timely and efficient manner.
- Monitor and assess current analytical methods and assists in improvements and amendments according to cGMP practices.
- Responsible for following policies, procedures, cGMPs and laboratory safety pertinent to the execution of duties. Ensure compliance is maintained in all areas of responsibility. - Contribute to the development and/or implementation of new technology in conjunction with supervisor.
- Assist in other parts of the department as workload and project priorities dictate. - Demonstrate development of technical and communication skills with a degree of professional maturity.
- May review work from various sources, may assign work to others, and may train less experienced employees.
- Participate as a team member, support the company mission and vision and contribute to the pursuit of the company's goals.
- Participate actively in regular meetings.
- Achieve expected performance measures.
- Other duties as assigned.
- Bachelors' Degree or equivalent in Chemistry or related science.
- 5+ years experience in analytical drug development in a pharmaceutical laboratory.
- 3+ years experience with HPLC, dissolution and classical analytical techniques.
- Experience in testing all aspects of solid dosage forms a necessity; controlled release and semi-solid testing experience a plus.
- Working knowledge of experimental designs, GMPs, clinical manufacturing, validation, and report writing for regulatory submissions.
- Proficient with interpreting and implementing cGMPs, cGLPs, ICH, USP, FDA, DEA and OSHA guidelines.
- Demonstrated ability to work and manage effectively in a fast paced environment.
- Must be able to manage multiple projects while maintaining efficiency and effectiveness.
- Excellent oral and written communication skill to communicate with the team, peers, management, and external contacts.
- Must have the ability to work effectively and independently.
- Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel.