Principal Scientist, Process Engineering

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 Title

Principal Scientist, Process Engineering

Location(s)

GSK (Collegeville) - Customer Site PA

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.
• Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.

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

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

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any

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