Administrative Shift - 8:00AM - 5:00PMDescription: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.
Responsibilities: - 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.
Job Requirements:- 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
Education: - 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.
