PURPOSE: To design, validate and transfer new or improved analytical methods in support of the Compounding business. To complete assigned method research and development projects as assigned.
Based on business needs, the Method Development Chemist will develop sound and scientific analytical methods which are validatable as per current USP and ICH guidelines. The Method Development Chemist will write technology transfer protocols and if necessary, train chemists in the new analytical method.
• Conduct method development, method validation and method transfer
• Prepare and conduct investigations in areas of method performance and reliability; evaluate proposed changes to established methods for the purpose of qualification in the QC Laboratory.
• Excellent oral and written communication skills for participating in problem-solving teams and customer visits, as necessary.
• Ability to work within given deadlines as required.
• Know commonly used analytical equipment, its function and operation. Such equipment includes HPLC, UV-Vis and IR spectrophotometers, gas chromatograph, liquid chromatograph, incubator, oven, analytical scale, centrifuge, etc.
• Maintain a chemically hygienic working environment.
• Conduct special projects as directed by Supervisor/Management.
• Train Laboratory and/or Chemist in new or transfer technology.
This position requires standing approximately 80% of the time due to laboratory bench work. Occasional assistance in product inspection (weekly) will require walking, bending, lifting (possibly up to 40 lbs. or more) as well as clerical, etc.
This position requires daily working with hazardous and toxic chemicals, dust, and fumes necessitating use of personal protective equipment such as safety glasses, face shields, respirators, fume hoods, etc.
PERFORMANCE STANDARDS: Within 90 days of initial employment, the Senior Chemist should be capable of running any of the standardized methods of analysis used in the lab.
Ability to make decisions and set priorities to include recognizing important elements of the job, estimating time needed to perform tasks, and drawing conclusions about problems/situations based on provided facts as needed to identify problems and recommend actions for solutions, schedule work for self and others, work without direct supervision, and respond to emergency situations.
Ability to interact with supervisors, co-workers, and public to include being flexible with work schedules and requests; remaining calm and courteous and exercising self control when sharing information and when interacting with angry individuals; accepting criticism without over-reacting or getting angry; and being open to and sharing ideas as needed to conduct training, handle complaints and encroachment situations, explain policies and procedures, and maintain good relations within the company.
A postgraduate degree in Analytical Chemistry is preferred.
Previous experience in writing and executing Method Validation protocols and reports.
2-7 years of experience in Method Development in a GMP Pharmaceutical Industry Quality Control Laboratory a must.
Familiar with GMP regulated industry.
Previous experience in performing and writing Laboratory Investigation.
Familiar with Monograph testing such as USP, FCC and BP.
Expert with Waters HPLC (UV/PDA detector) , GC (packed/capillary FID), UV/Vis, FTIR, and commonly used analytical instrumentation.