Process Development Sr Scientist
About The Position
For Validation and Scientist Services in the Process Development area. This role requires a Bachelor's Degree with five (5) 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. Experience in sterile drug product manufacturing, aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process is required. The role also involves executing validation protocols, characterization studies, technical reports, investigations, and change controls. The ideal candidate will possess multitasking, scientific, and creative skills, thriving in an environment of healthy competition, teamwork, ethical behavior, and the use of the scientific method.
Requirements
- Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Experience in Sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
- Experience in Aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process.
- Experience in Executing validation protocols, characterization studies, technical reports, investigations, and change controls.
Responsibilities
- Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies.
- Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations.
- Expands knowledge-seeking beyond core area of expertise.
- Identifies relevant external competitive knowledge.
- Independently prepares new and novel protocols/experimental design.
- Key contributor to an independent research/project team.
- Initiates productive collaborations outside of the department or company.
- Introduces new or advanced technologies and/or concepts.
- May contribute to scientific journal articles or complex technical documents as lead author.
- Leads department-wide support efforts such as safety, recruiting and committees. Develops supervisory and mentoring skills.
- Makes proactive decisions that contribute to the achievement of milestones.
- Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
