Chemist I will perform wet chemistry and analytical testing utilizing AA, UV-Vis, HPLC, GC and other lab instruments. Plan and execute laboratory experiments, technical activities, and professional services, coordinating all necessary resources. Experience in one or more of these instruments are preferred. Must be able to perform within cGMP regulations, FDA and ICH guidelines. Good comprehension of USP, EP and other compendial methods and procedures is a plus. Demonstrated ability to work independently and effectively on assigned projects in a timely manner. Demonstrated ability to manage multiple projects and meet critical deadlines. Must have excellent written and verbal communication skills and ability to work in a team oriented environment. Requires a B.S. in Chemistry or a related field and minimum 2 to 4+ year of pharmaceutical experience.

The qualified candidate must be able to perform within cGMP regulations, FDA and ICH guidelines. Should have proficient knowledge of general analytical chemistry techniques, gas and liquid chromatography, HPLC, dissolution and wet chemistry. Experience in one or more of these instruments are required. Good comprehension of USP, EP and other compendial methods and procedures is also necessary. Requires a B.S. in Chemistry or a related field and minimum 4 to 6+ year of pharmaceutical experience. Demonstrated ability to manage multiple projects and meet critical deadlines. Maintain and write laboratory reports. Successful candidates must be proactive and creative, well organized, willing to work both independently and as a team player, and have excellent communication skills.

Demonstrated ability to manage multiple projects and meet critical deadlines.

Successful candidates must be proactive and creative, well organized, and have excellent communication skills.

Create and revise departmental and test procedures, SOP’s etc. Comply with all cGMP regulations, FDA and ICH guidelines, safety requirements, laboratory SOPs and company policies and procedures. Issue reports and experimental results, etc.

Responsible for assigning the training of new analysts, reviewing their training records. Responsible for reviewing all analytical data generated, sign and date notebook and initial job worksheet, before analyst inputs results into database.

Responsible for ordering chemicals, standards, lab supplies, etc., in order to get the work done on time.

Ensure that all instruments, used in their areas, are in good working conditions and that calibrations and maintenance records are up to date.

Support and train all lab technicians and associate chemists. Provide technical support in the maintenance of lab systems and instrumentation.

10%: Perform Lab Testing, 60%: Support Documentation Efforts, 20%: Support and Train

• Requires a B.S. in Chemistry or a related field and minimum 8 to 10+ years of recent pharmaceutical experience in a cGMP, ICH, FDA regulated environment, 2 - 3 years of supervisory experience a must!
• Good Excellent oral and written communication skills
• Proficient knowledge about FDA, USP, EP and ICH Regulatory Guidelines