Process Development Sr Scientist ID 35535

To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.

• →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.
• Experience in filling validation and work on technical documentation.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• 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.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• 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.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable
• Experience with technical data analysis and scientific documentation

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or 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 is preferred.