Pharmaceutical Development Technician
About the role
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Position Summary
- The Pharmaceutical Development Technician in the Kilo Lab is primarily responsible for maintaining plant cleanliness and housekeeping standards, along with assisting scientists in the lab by efficiently staging and removing materials such as raws, intermediates, products, and hazardous waste, ensuring an organized and safe manufacturing environment. The position also entails setting up, operating, monitoring, and cleaning process/utility equipment. As well as executing unit operations such as reactions, filtrations, distillations, and drying, while performing data collection in compliance with cGLP and cGMP regulations. Proficiency in operating manufacturing equipment, recognizing abnormal operating conditions, and working in specialized environments, such as clean/aseptic and high potent containment areas, using established handling procedures is essential. The Kilo Lab's purpose is to provide knowledge and manufacture Active Pharmaceutical Ingredients (API) and Antibody-Drug Conjugates (ADC) for clinical and non-clinical demands across the entirety of the BMS portfolio.
Duties/Responsibilities
Assignments in clinical and non-clinical manufacturing include, but are not limited to the following:
- Support the Kilo Lab Operations team with process scale-up activities.
- Set up, operate, sample, clean and data acquisition (electronic and manual collection) from all process and utility equipment required in the manufacturing process such as reactors, dryers, mills, pumps, meters, tanks, scrubbers, etc.
- Executing and documenting all unit operations such as reaction, extraction, distillation, crystallization, filtration, drying, mixing, milling, filling, lyophilization, solids handling, and other new and available technologies when needed.
- Proper operation of process controls such as Delta V, pneumatic equipment, etc.
- Staging and storing materials such as raw materials, intermediates, products, hazardous waste, etc.
- Recognize abnormal operating conditions with proper response including immediate notification to supervision.
- Maintain plant cleanliness and housekeeping standards.
- Record data as per cGLP and cGMP regulations in both paper and computer formats, per established procedures.
- Strict adherence to GMP, federal, state, and local regulations is required.
- Proficiency in operating and understanding principles of commonly used manufacturing equipment and test equipment used for in-process testing must be demonstrated following training. Some projects will require working in clean/aseptic areas and high potent/containment areas using established handling procedures.
Qualifications
- Two-year Associate Degree in science or equivalent. Partial completion of a Bachelor Degree in science or equivalent, or demonstration of accredited specialized process engineering training program would be considered in lieu of Associate Degree.
- Practical experience working in a laboratory setting would be highly desired, especially if it involved Active Pharmaceutical Ingredient (API) manufacturing.
- cGMP experience in the pharmaceutical industry, is highly desired.
- Attention to detail is critical for both compliance and safety.
- Proficiency in the use of computer programs/systems, is essential. Including but not limited to SAP, DeltaV, and Microsoft Office suite.
- Ability to work independently and collaborate with scientists, is essential.
- Excellent oral communication skills with the ability to communicate effectively across diverse teams.
- Flexibility and adaptability to learn new technologies and processes as required, demonstrating eagerness to contribute to innovation and operational excellence.
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.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
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