Underwriter, Senior

Perform analytical testing for drug substances and various drug products such as tablets and capsules. Analyze exhibit batches, process validation batches, related stability testing. Perform method transfer and validation. Support lab investigation. Compile ANDA submission documents.

Experience :

• Minimum of ten (10) years of experience in pharmaceutical analytical laboratory
• Experience with analytical instrumentation, theory and practice.
• Experience with wet chemistry techniques.
• Excellent written and verbal communication skills.

Duties and Responsibilities :

• Performs routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyzer, etc.
• Responsible for the timely execution of lab analysis and related documentation.
• Concurrent documentation of all the raw data, observations in the worksheets/templates/notebooks.
• Compile the analytical data and notify the results to supervisor.
• Perform QC testing of exhibit batches.
• Perform the testing of process validation/characterization batches and stability samples.
• Compile the data for ANDA submission and provide to RA/ODR.
• Perform the tracking and trending of lab data.
• Perform training of junior chemist.
• Support Manager for daily laboratory operation and planning.
• Adhere to safety, DEA procedures, and department SOPs.
• Perform calibration of analytical instruments.
• Perform qualification of working standards.
• Execute method transfer and method validation.
• Keep the working place clean and tidy.
• Create and maintain clear and concise lab records and documentation (notebooks and computer-based).
• Perform routine maintenance of lab equipment as needed.

Work Conditions :

• Environmental related to manufacturing/production/warehouse environments:
• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
• Close vision; depth perception; ability to adjust focus.
• Use of repetitive motion.
• Able to operate computer/office machines.
• Able to lift and carry up to 50 lbs.

Qualifications / Education :

• Minimum BS or equivalent degree in Chemistry or related discipline, MS preferred.
• Understanding of GMP, ICH and FDA guidelines.
• Proficient with Microsoft Office applications such as Excel.
• Excellent written and verbal communication skills.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem-solving skills.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).