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 testing 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. Evaluation of Individual performance as compared to job function and BMS core behaviors will be evaluated throughout the year.
EDUCATION REQUIREMENTS:
Bachelors' degree with a major in biology, or an allied science and coursework in microbiology from an accredited college or university. Must have a minimum of 1 year experience In pharmaceutical microbiology, especially In parenteral and/or aseptic operations. Proficiency in use of computer programs/systems Is essential. Bacteriologists must maintain their skills and knowledge to stay current with advances In the field of microbiology. Bacteriologists may attend internal or external training courses as approved by management.
Laboratory skills training will be implemented to ensure 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. Bacteriologists 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.
The position will require the employee to work with chemical, radiological and biological agents that may be hazardous to health If mishandled (including agents which may potentially affect the development of a fetus). Assignments will be executed in laboratories. Employee will be required to follow all safety procedures and use personal protective clothing/equipment as provided by the company where specified. Disagreeable conditions including odors, heat, noise, etc. may be experienced. Some projects will require working in high containment areas using established handling procedures.
JOB FUNCTION:
Performs microbiological testing to ensure that the proper standards of quality are maintained. Performs microbiological, bacterial endotoxin, total organic carbon and conductivity analyses of water system samples. Performs environmental monitoring and water sampling in support of the routine operations and manufacturing. Demonstrates the use of aseptic technique. Analyzes, develops and recommends new methods for the improvement of various standard assays and tests. Carries out analytical tests and inspections in connection with the investigation of product and environmental monitoring excursions. Evaluates results and submits documentation for approval. Performs routine maintenance and calibration procedures on laboratory instrumentation. Troubleshoots equipment and methods for investigational purposes. Performs laboratory support activities such as stock culture maintenance and laboratory Inspections, as assigned.
Responsibilities Include maintaining laboratory documentation, samples, and equipment under strict compliance with safely, GMP, federal, state and local regulations. Maintains laboratory notebook (paper or electronic}, record/capture records raw data, calculates results and submit results to laboratory supervisor and/or computer database following Good Documentation Practices. Responsible for reporting to supervisor any anomalies or irregularities that may occur during the performance of any and all assigned assays. Prepares, updates or assists In the revision of SOP's, training documentation and departmental forms to reflect current laboratory practices. Cross-trains to ensure full functionality on all laboratory equipment and methods. Trains other employees in the analytical techniques, SOP's, GMP's, administrative and safety procedures In the laboratory as required.
