Pharmaceutical Development Technician

Permanent – Pharmaceutical Development Technician, Analytical Research – 25 – ASO

Shift: 7 AM – 3:30 PM EST

Site: New Brunswick, NJ

Building: #105 (excluded)

Rate: $42.04 / hour

The goal of pharmaceutical development within Research & Development is to develop new drug candidates and the processes to manufacture them into commercial realities. This is achieved by designing and conducting a variety of experimental studies using the latest scientific methods and state‑of‑the‑art equipment and instrumentation. The development process is very dynamic with studies performed in both laboratory and process scale‑up facilities.

Scientific rigor, timeliness and compliance with all GLP and federal/state/local regulations are a necessity.

In order for the development process to be successful, there must be excellent collaboration between the professional staff/scientist and union staff. Often, the professional staff/scientist will need to take a hands‑on approach during the course of an experiment as necessary based on sound scientific judgment. Involvement of union staff in the various experimental studies and other processes is determined by the professional staff/scientists on a case‑by‑case basis because of the non‑routine, dynamic nature of the development process.

Work assignments will be based on demonstrated technical competence of the individual technician and the demands of the process. Priorities will be set based on the needs of the R&D business. Both written procedures and verbal instructions by a supervisor will be executed with strict attention to safety and quality. Accurate and timely execution and documentation of activities and results are a requirement.

Strict adherence to cGLP/GMP, federal, state and local regulations is required. In order to achieve departmental and company goals, collaborative work with other employees (both professional and union) is a requirement.

Job Function:

Carries out assigned laboratory responsibilities which may include performance of a variety of tests or analysis. Assists in development, execution, and validation of analytical methods and routine sample analysis under the direct supervision of a professional/scientist or laboratory supervisor. Able to work independently in the analysis of routine pharmaceutical development samples.

Technicians are expected to follow a written procedures and/or carry out verbal instructions with appropriate supervision, both independently or as part of a team. Familiarity and demonstrated competency (after training) is required with test equipment that includes but is not limited to the following: high performance liquid chromatography (HPLC), gas chromatography (GC), spectrophotometers, IR/Raman spectrometers, fluorimeters, polarimeters, dissolution instruments, volumetric and gravimetric analyzers, balances, pH meters, and other analytical instruments including computers and automated systems.

Common equipment will be used by technicians and scientists dependent upon the requirements of the assay as determined by the laboratory supervisor. Laboratory responsibilities include, but are not limited to, the following: preparation and proper labeling of standards, samples, reagents, including mobile phases for HPLC analysis and dissolution media, sorting glassware for storage or cleaning, collecting waste solvents for disposal, and general laboratory housekeeping.

Some projects will require working in high containment areas using established handling procedures.

Responsibilities include maintaining laboratory documentation and equipment in strict compliance with safety, GLP, GMP, federal, state, and local regulations. Make adjustments and/or minor repairs to instruments and equipment as dictated by Instrument Operating Procedures (IOPs). Responsible for reporting to supervisor any anomalies or irregularities that may occur during the performance of any and all assigned assays. Maintain laboratory notebooks (paper or electronic) record/capture raw data, calculate results and submit results for supervisor review/approval.

Education Requirements:

• Two-year Associate Degree in Science related to pharmaceutical development or equivalent.
• Pr…