Process Development Sr Scientist

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.

• →Designs, monitors, or conducts 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 technical expertise and areas relevant to their function.
• →Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• →Develop and implement 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 implementing innovative remedies.
• →Able to develop solutions to routine technical problems of limited scope.
• →Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Validation experience in highly regulated industry. If possible, filling validation and work on technical documentation.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required.
• Fully bilingual (English/Spanish).

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable
• Master's degree with 3+ years of relevant scientific experience; or bachelor's degree with 5+ years of relevant scientific experience.
• Science background as Engineering or microbiology