Sr. Scientist

Conduct chemical, biochemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability. Perform laboratory investigations for OOS results or other exceptions. Proficiently uses analytical instrumentation and troubleshoots equipment issues. Write/ revise standard operating procedures, protocols, test methods and change controls as needed.

Resolve problems and implement corrective and preventive actions. Write/ revise standard operating procedures, forms, protocols, test methods, and change controls as needed. Work independently in areas needed, provide guidance to less senior staff and fill in for supervision/management when necessary.

 

1. Conduct critical chemical, biochemical and physical analyses on incoming components, raw materials, initial, in-process, final products and stability, and samples collected from water for injection systems at Hikma manufacturing facilities, along with customer compliant, foreign vials and retain samples.
2. Work on special projects / protocol testing that involves new methods and instrumentation.
3. Assist supervision with laboratory investigations for OOS results or other exceptions.
4. Write and execute validations for laboratory instruments and methods.
5. May serve as mentor to other Quality Laboratory positions. Provide training and work direction for Quality Laboratory Associate I and II positions as required. Manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
6. Perform review of test data, which includes overall cGMP documentation practices and release functions in LIMS or other computerized systems.
7. Use sophisticated laboratory instrumentation (HPLC, GC, FTIR, AA, UV/Vis, ICP-MS, etc.) and computer systems to collect and record data.
8. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
9. Complete all testing, including special project / protocol testing in a timely and appropriate manner.
10. Execute validation studies in support of manufacturing processes and R&D projects including but not limited to cleaning validation, process validation, light filter tubing studies and method transfer/validations.
11. Conduct reference standard qualifications
12. Maintain data integrity and ensure compliance with company SOPs and specifications, USP, Ph.Eur., FDA, GLP, GDP and cGMP regulations.
13. Investigate deviations and write exception documents.
14. Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
15. Execute appropriate investigative testing to find or support root cause. Develop and implement appropriate corrective and preventative actions to eliminate repeat occurrences. Serve as expert investigator and perform trending of investigations.
16. Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs and Job Aids.
17. Work independently in areas needed, provide guidance to less senior staff and fill in for supervision/management when necessary.
18. Perform equipment maintenance and calibrations as required, troubleshoot and resolve instrumentation issues and participate in new instrument qualifications.

 

Bachelors Degree in Chemistry or related science with minimum of 10 years' experience in Pharmaceutical industry, or Masters Degree in Chemistry science with 5 years' experience.

 

1. Must be recognized by all levels of the facility as an expert in area and be able to demonstrate leadership.

2. Excellent organizational and project management skills and ability to handle multiple projects.

3. Must have excellent writing skills and ability to present data in a logical manner.

4. Good interpersonal, communication, influencing, leadership, and negotiation skills

5. Understand scientific strategies and be able to invent new methods or new avenues of investigation

6. Demonstrated effectiveness in task completion, decision making, and problem solving

7. Working knowledge of FDA regulations, application of GLPs and GMPs).

8. Experience interacting with personnel from regulatory agencies preferred.

9. Proficient in wet and instrumental methods of analyses
10. Advanced laboratory skills, knowledge of statistical method.
11. Strong technical problem solving skills
12. Ability to handle multiple tasks concurrently, and in a timely fashion
13. Computer literate.
14. Must be able to communicate effectively with supervisors and peers.
15. Must demonstrate eff