Associate Principal Scientist – Engineering
| Company | Inventing for Life |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor of Science (BS) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with ten (10) years in related field; OR
- Master of Science (MS) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with eight (8) years in related field; OR
- PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with four (4) years in related field
- Technical expertise in purification of biological and/or vaccine molecules, including laboratory models for chromatography or filtration systems.
- Experience with technology transfer or scale-up of processes to pilot and manufacturing scales for biologics and/or vaccine manufacture.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of purification process science, to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Responsibilities
- Participates in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation with line-of-sight for licensure and commercialization.
- Responsible for laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring and for further technical investigations and process improvement changes.
- Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams.
- Authors required regulatory and technical documentation. Ensures that processes are developed and documented according to our Company standard practices.
Preferred Qualifications
- Deep technical knowledge of harvest, preparative chromatography, tangential flow filtration, and/or normal flow filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations.
- Technical operations experience in the manufacture of biological and/or vaccine molecules at the pilot or commercial scale.
- Prior experience in late-stage process development, process characterization, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and working with external contract organization for development and or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (JMP or Design Expert software).
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics and/or vaccine processes.
- Working understanding of analytical methods to characterize biologics and/or vaccines and cGMP US/EU regulatory requirements.
- Prior managerial experience.