Pharmaceutical Development Technician
About the Job
Squibb is a global biopharmaceutical company whose mission is to discover,
develop and deliver innovative medicines that help patients prevail over
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The goal of Pharmaceutical Development within R&D 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 & instrumentation. The development process is dynamic with studies performed in both laboratory and process scale-up facilities. Scientific rigor, timelines and compliance with all cGLP/GMP 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 and union staffs. Often, the professional staff will need to take a hands-on approach during the course of an experiment as necessary based on sound scientific judgement. Involvement of union staff in the various experimental studies and other processes is determined by the professional staff on a case by case basis because of the non-routine dynamic nature of the development process.
Daily 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 qualify. 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. Collaborative work with other employees is a necessity to achieve departmental and company goals.
WORKING CONDITIONS (Applicable to all areas\: API Operations & CSD)\:
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 development of the fetus). Assignments may be executed in laboratory, process scale-up facilities, and warehouse. 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 and activities will require working in Band 5/containment areas using established safety and handling procedures.
Responsibilities include maintaining documentation interface with laboratory and inventory information management systems, facilities and equipment under strict compliance to GLP, GMP, federal, state and local regulations.
API Operations Glass & Pilot Plant activities include, but are not limited to\:
- Executing and documenting with strict attention to quality and safety unit operations such as distillation, crystallization. Reaction, extraction, filtration, solids handling, subdivision and sizing, etc.
- Set-up, operations, sampling, clean-up of process areas.
- Data acquisition from (including electronic and manual collection) both manual and computer controlled process and utility equipment such as reactors, centrifuges, dyers, mills, pumps, meters, tanks, thermal oxiders, temperature controller modules, scrubbers, etc. will be required.
- The assignments will be performed based on written or verbal instructions from supervisor and/or professional staff.
- Training will be implemented to ensure PDT employees receive relevant training to facilitate the performance of their job responsibilities.
- Proficiency in operating and understanding principles of commonly used equipment and test equipment used for in-process testing must be demonstrated following training.
- Some projects will require working in cleans/aseptic areas and anti-cancer/containment areas using established handling procedures.
API Operations & CSD Laboratory and preparative experiments include, but are not limited to\:
- Preparation of buffers and other media
- Physical, chemical, and mechanical analysis
- Lab experiments and preparative experiments (set-ups, reagent prep, solutions)
- Waste handling, sorting glassware for storage or cleaning, and general laboratory housekeeping and cleaning
- Familiarity and demonstrated competency after training with testing equipment including but not limited to\:
- HPLC systems
- GC systems
- Automated UV-diode array systems
- Balances and pH meters
- Powder characterization equipment, calorimetry characterization equipment,
- NIR, RAMAN,
- ROI, LOD, KF, etc.
- Procurement of consumables, solvents, and chemicals to support daily lab operations
- Responsible for reporting to supervisor any issues or irregularities that may occur when conducting lab work or equipment verifications
- If applicable, maintain laboratory notebooks (electronic or paper) to record/capture data, calculate results and submit completed to supervisor for witnessing
- A minimum of 5 years’ direct experience in a heavily regulated (e.g. OSHA, PSM, cGMP) manufacturing and/or research & development environment with a strict adherence to established safety and cGMP rules and regulations performing the activities within the “Job Function” section of this Job Description is required.
- Experience in bulk fine chemicals, bulk API, or petro-chemical organic processing is preferred.
- A two-year Associates Degree in a Science related discipline is preferred.
- Proficiency in use of computer programs/systems is essential.
- Technicians must maintain their skills and knowledge current with advances in the field of pharmaceutical development. Incumbents may attend internal or external training courses as approved by management.