Process Development Scientist
About The Position
For Scientist Services in the Process Development: Inspection Projects area. This role requires a Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry. Bilingual (English & Spanish) and Project Management skills are essential. The shift is administrative, and according to business needs, potentially including irregular shifts, extended hours (12 hrs), nights, weekends, and holidays. Experience in inspection project management, Lean Six Sigma, operational excellence, continuous improvement methodologies, experimental design, data analysis, scientific method application, GMP guidelines, regulatory compliance, and protocol-driven studies is required. The ideal candidate possesses multitasking, scientific, and creative skills, thrives in an environment of healthy competition, teamwork, and ethical behavior, and consistently applies 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 Inspection project management — phases, planning, and execution.
- Experience in Lean Six Sigma, operational excellence, and continuous improvement methodologies.
- Experience in Experimental design, data analysis, and scientific method application.
- Experience in GMP guidelines, regulatory compliance, and protocol-driven studies.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
