Pharmaceutical Development Technician

Bristol Myers SquibbNew Brunswick, NJ
Onsite

About The Position

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 staffs. 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.

Requirements

  • Two-year Associate Degree in Science related to pharmaceutical development or equivalent.
  • Proficiency in use of computer programs/systems is essential.
  • Technicians must maintain their skills and knowledge to stay current with advances in the field of pharmaceutical development analysis.
  • 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, is required.
  • Strict adherence to cGLP/GMP, federal, state and local regulations is required.
  • Accurate and timely execution and documentation of activities and results are a requirement.

Nice To Haves

  • Pharmaceutical development technicians may attend internal or external training courses as approved by management.
  • Laboratory skills training will be implemented to ensure PDT employees receive relevant training to facilitate the performance of their job responsibilities.
  • Interactive training modules (i.e. On-The-Job Training) will be used for training on specific competencies.
  • Competency check after training specific to an area will be conducted to evaluate proficiency of the new skill (or module).
  • If required proficiency is not obtained the interactive learning and testing will be repeated.
  • A pass/repeat summary of all testing on each module will be kept to assess the performance of the module.
  • Pharmaceutical development technicians will be required to demonstrate competence after training as assessed by their management.
  • In the event competence is not demonstrated, re-training will be provided.
  • Required refresher training including laboratory safety and compliance must be kept up to date.

Responsibilities

  • 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.
  • 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.
  • 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).
  • 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.

Benefits

  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
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