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Process Development Scientist (Vial/Syringe Filling Process)

Juncos, PR
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor. Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

On the floor support/troubleshooting activities of the formulation and filling process. Provide support to investigations by participating in the root cause analysis, and providing product impact assessments. Own investigations and process monitoring assessments. Lead characterization activities by developing the design of the studies, protocol, training and execution of the characterization protocol.

Doctorate degree Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.

  • Available for Administrative hours and non-standard shift if needed (extra hours, weekend & holidays)
  • Experience supporting manufacturing operations in the following areas: Formulation of Oral Parenteral Products, Vial Filling Process & Syringe Filling Process
  • Knowledge of process monitoring, statistical knowledge and proficient in the use of minitab or JMP will be required
  • Excellent technical writing skills
  • Fully bilingual (Spanish/English)

Ultimate Solutions Corp is an equal opportunity employer.

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