Principal Scientist – Process Engineering
| Company | PerkinElmer |
|---|---|
| Location | Phoenixville, PA, USA |
| Salary | $87360 – $131040 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 1-3 years of protein formulation and drug delivery development experience
- OR Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 5-7 years of similar experience in protein formulation and drug delivery development experience
- OR Bachelor’s degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 10 or more years of similar experience in protein formulation and drug delivery development experience
Responsibilities
- Conduct laboratory experimentation and analytical testing of putative formulations & drug product manufacturing
- Follow administration/delivery approaches for select protein therapeutic assets, including contributing to, the conception & evaluation of conventional & novel product matrices and administration modalities
- Partner closely with the manufacturing groups during process development and technology transfers
- Actively participate with combination drug product assessment and collaborate with device engineering
- Physicochemical and bioanalytical characterization of native and modified biopharma compounds
- Collaborate with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development
- Oversee release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
- Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols
- Assess resultant data; working closely with internal & external discovery and development support partners as needed
- Maintain accurate, complete laboratory records and ease use of electronic data & information gathering, capture, archiving and communications techniques
- Assist in preparation and review of manufacturing batch records, SOPs, and regulatory documentation as appropriate
- Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.
Preferred Qualifications
- Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically based experimental design/interpretation approaches.
- Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
- Experience and understanding of multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), DSC, particles evaluation by HIAC and/or orthogonal techniques (eg MFI, FlowCam, Archimedes), capillary electrophoresis & chip-based methods, etc.
- Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, BLA/MAA filings, response to regulatory questions, and pre-approval inspection experience.
- Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities
- Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.