Principal Scientist, Process Engineering

Principal Scientist, Process Engineering

When joining Perkin Elmer, 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 One Source services.

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 Bio Pharma Product Development & Supply organization. The role will center on developing drug product, manufacturing process and delivery systems for protein & peptide-based therapeutics.

Job 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.

The selected candidate must possess knowledge and/or competencies related to:

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

Job Requirements and

Qualifications:

Basic

Qualification:

(Required Education & Experience)

• 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

Preferred Experience:

(candidates who meet BQs & these qualifications (PQs) especially qualify to be shortlisted for candidate submission)

• 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, Flow Cam, 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.

Physical Demands

• Must be able to remains in a stationary position more than 25% of the time
• The person in this position needs to occasionally move inside and outside labs
• Frequently operate on instruments, objects, tools or controls, which will require regularly…