The Role
Lead design and execution of experiments for sterile drug product process development and validation. Support aseptic filling, process characterization, PPQ, technology transfer, and commercial readiness. Analyze data (JMP/Minitab), author validation protocols and technical reports, work cross-functionally to ensure GMP compliance and contamination control, and drive continuous process improvements.
Summary Generated by Built In
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift - 8:00AM – 5:00PM
Description:
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.
Skills Required
- Experience supporting sterile drug product manufacturing within pharmaceutical or biotechnology industry.
- Validation experience in highly regulated industry.
- Experience in filling validation and 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.
- Education: Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience; or Master's degree with 3+ years relevant experience; or Bachelor's degree with 5+ years relevant experience.
- Science background in Engineering or Microbiology.
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The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
