Sr. Scientist – Process Engineering
| Company | PerkinElmer |
|---|---|
| Location | Phoenixville, PA, USA |
| Salary | $71240 – $106600 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior |
Requirements
- PhD in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field OR
- Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field and 3-5 years of similar experience in protein formulation and drug delivery development experience OR
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Physics, mechanical engineering or any engineering field and 5-7 years of similar experience in protein formulation and drug delivery development experience.
Responsibilities
- Work as a principal engineer/scientist in a multi-disciplinary development team, liaising efficiently with Formulators, Modelers, automation experts, data scientists and device engineers, to deliver the work packages required to understand drug product unit operations and scale these-up effectively.
- Actively participate in technical reviews on projects, lead the scale-up of processes, and ensure timely execution. Contribute to CMC and MPD team planning, agreeing priorities and coordinating PE&A activities that support delivery of objectives.
- Ensure proper Process Engineering and PAT related decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and minimize number of DOE’s for scalability assessments and API consumption throughout the development life-cycle.
- Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing and/or PAT platforms. Be accountable for manufacturing and/or PAT platform robustness across the portfolio.
- The job holder may act as an expert in specific unit operations and/or PAT technology. This expertise will be focused on platform and process primarily within the sterile portfolio.
- Prepare and deliver Process Engineering and Analytics-relevant sections of technical presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews.
- Advance scientific understanding and improve current ways of working in field of expertise by actively championing deployment of new process engineering platforms, PAT tools and models for drug product development, participating in internal or external technical focus networks, external collaborations, and applying knowledge of the current literature.
- Enable sound decisions by your influence in matrix teams, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites.
- Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.
- Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.
Preferred Qualifications
- 2+ years of Steriles drug product – Process Engineering development and/or PAT experience; or MS degree with 5+ years of similar experience; or BS degree with 7+ years of experience.
- Experience in Steriles drug product process development, PAT, characterization, scale -up and technology transfer modelling, and, to deliver processes that are well understood.
- Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
- Experience evaluating, developing, and qualifying manufacturing equipment.
- Proven ability to lead collaboratively in a matrix style environment.
- Steriles product development including formulation, stability, process development/characterization and technical transfer.
- analytical and physical testing, and data analysis.
- Demonstration of data integrity principles.