Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The goal of Pharmaceutical Development within Research & Development (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 and instrumentation. The development process is very dynamic with performed in both laboratory and process scale-up facilities. Scientific rigor, timeliness 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 judgment. Involvement of the 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 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. Collaborative work with other employees is a necessity to achieve departmental and company goals.
EDUCATION REQUIREMENTS:
Two year Associate Degree in Science related to Pharmaceutical Development or equivalent (required for Manufacturing role) or Business related to Operations/Supply Chain/Logistics or equivalent (Integrated Supply Chain and Logistics). Proficiency in the 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. In lieu of a two year degree, four years of experience in a pharmaceutical environment or related field and/or satisfactory completion of Bristol Myers Squibb Co, in-house training will meet requirements.
Training will be implemented to ensure PDT employees receive relevant training to facilitate the performance of their job responsibilities. Testing after training specific to an area will be an ongoing requirement. Interactive training modules will be used for training on specific competencies. If testing is not passed, 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.
WORKING CONDITIONS:
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 will be executed in laboratory, warehouse and process scale-up facilities interchangeably. The 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.
JOB FUNCTION – CLINICAL SUPPLY OPERATIONS INTEGRATED SUPPLY CHAIN
Assignments within Integrated Supply Chain include, but are not limited to the following:
- Weigh, dispense and accurately label bulk drug substances, ingredients, dosage forms, packaging components, and all materials needed to support clinical programs and product development
- Withdraw samples from material containers, transfer materials between buildings and within buildings by means of hand trucks or fork lifts
- Setup, clean and operate all areas and equipment required in the weighing and dispensing process
- Record data as per cGLP and cGMP regulations in both paper and computer formats, per established procedures
- Maintain the warehouse, dispensaries and other operations areas in neat and tidy conditions
- Perform the receipt, reconciliation and put-away of inbound materials
- Pack and ship both regular and temperature controlled, domestic as well as international shipments
JOB FUNCTION – CLINICAL SUPPLY OPERATIONS REGIONAL LOGISTICS
Assignments within Regional Logistics include, but are not limited to the following:
- Perform the physical and system pick of finished clinical supplies for domestic and international shipments, ensuring the accuracy of the items picked to the container level
- Pack finished clinical supplies for domestic and international shipments
- Pack temperature controlled shipments to maintain temperature range specified for the product, according to the provided cold chain packing guidelines
- Perform inventory/cycle counts of finished supplies within New Brunswick
- Perform drug re-labeling activities and domestic and international shipment labeling
JOB FUNCTION -MANUFACTURING
Assignments in clinical manufacturing include, but are not limited to the following:
- Set up, clean and operate all equipment required in the manufacturing process;
- Weighing of ingredients;
- Perform all unit operations such as: granulation, mixing, drying, filtering, milling, sterile filling, lyophilization, coating, tabletting, encapsulating and other new and available technologies when needed;
- Record data as per cGLP and cGMP regulations in both paper and computer formats, per established procedures.
Proficiency in operating and understanding principles of commonly used manufacturing equipment, for example, high shear mixers, tablet press, encapsulating machines, tablet coaters, fluid bed granulators, compactors, lyophilizers, autoclaves, etc., and test equipment used for in-process testing must be demonstrated following training. Some projects will require working in clean/aseptic areas and anti-cancer/containment areas using established handling procedures.
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.
