Principal Scientist, Process Engineering

PerkinElmer•Collegeville, PA

1d•$110,000 - $130,000•Onsite

About The Position

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job TitlePrincipal Scientist, Process Engineering Location(s) GSK (Collegeville) - Customer Site PA Job Description About PerkinElmer Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere. Our dedicated team of about 16,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally. If you are seeking a meaningful, impactful, and stimulating career, look no further. Job Summary: We are looking for a highly motivated candidate to join our Process Engineering and Modeling team within the Biopharmaceutical Product Sciences (BPS) department, of the BioPharma Product Development & Supply organization. The role will center on developing drug product, manufacturing process and delivery systems for protein & peptide-based therapeutics.

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
Protein and peptide chemistry
Formulation and drug delivery/device development
Drug product manufacturing

Nice To Haves

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.

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.