Process Development Scientist-03

Flexible & Integrated Technical Services, LLC•Juncos, PR

7d•Onsite

About The Position

This role is for a Scientist Services position within the Process Development: Inspection Projects area. The ideal candidate will have a Bachelor's Degree with four years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual (English & Spanish) and Project Management skills are required. The position involves administrative shifts according to business needs and requires experience in formulation and aseptic filling operations, process monitoring, data trending, statistical analysis tools, deviations, investigations, root cause analysis, and product impact assessments. The role is suited for someone with multitasking, scientific, and creative skills, who thrives in an environment of healthy competition, teamwork, ethical behavior, and the use of the scientific method.

Requirements

Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Experience in formulation and aseptic filling operations.
Experience in process monitoring, data trending, and statistical analysis tools.
Experience in deviations, investigations, root cause analysis, and product impact assessments.

Responsibilities

Conceives, designs, executes, 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 the supervisor.
Provides data analysis and interpretation and assesses the impact of the data on the project.
Keeps current in the 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 the 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 implements innovative remedies.
Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions, and/or patents.
Participates in the external scientific community.
May assume a 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 teamwork.