Principal Scientist, Process Engineering

PerkinElmer; Collegeville (PA); On-site; USD 110,000 - 130,000; Full time

Job summary

PerkinElmer in Collegeville, PA, seeks a Principal Scientist, Process Engineering to lead development of protein and peptide delivery systems and associated manufacturing processes. You will design experiments, guide process development, and support tech transfers with manufacturing teams to ensure scalable, robust drug product formulations.

The role requires advanced degrees and significant experience in biopharmaceutical formulation and analytical characterization.

Qualifications

• PhD/masters/bachelors with extensive protein formulation and drug delivery development experience.
• Experience with DOE and statistically based experimental design/interpretation approaches.
• Experience with protein product manufacturing processes and development and tech transfer.

Responsibilities

• Conduct laboratory experimentation and analytical testing of putative formulations and drug product manufacturing.
• Collaborate with manufacturing groups during process development and technology transfers.
• Oversee release and stability testing; craft and execute non‑GMP stability protocols to evaluate quality and stability of product formulations.
• Engage with Analytical Technology Transfer and Stability group to craft GMP stability protocols.
• Assess data in collaboration with discovery and development partners.
• Maintain accurate laboratory records and support regulatory documentation as appropriate.

Skills

Protein formulation

DOE/experimental design

Analytical characterization

Regulatory submission support

Cross-functional collaboration

Education

PhD in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related

Master’s in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related

Bachelor’s in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related

Tools

HPLC

SDS‑PAGE / CGE

SEC

DSC

Capillary electrophoresis

Job description

Principal Scientist, Process Engineering – GSK (Collegeville) • Customer Site, PA

Job Summary

Join the Process Engineering and Modeling team within Biopharmaceutical Product Sciences to develop drug product, manufacturing processes, and delivery systems for protein and peptide‑based therapeutics.

Responsibilities

• Conduct laboratory experimentation and analytical testing of putative formulations and drug product manufacturing.
• Follow administration/delivery approaches for select protein therapeutic assets, contributing to the conception and evaluation of conventional and novel product matrices and administration modalities.
• Partner closely with manufacturing groups during process development and technology transfers.
• Actively participate in combination drug product assessment and collaborate with device engineering.
• Perform physicochemical and bioanalytical characterization of native and modified biopharma compounds.
• Collaborate with the Bioanalytical Sciences group to develop and transfer stability‑indicating analytical methods for use in product development.
• Oversee release and stability testing; craft and execute non‑GMP stability protocols to evaluate quality and stability of product formulations.
• Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols.
• Assess resultant data in collaboration with internal and external discovery and development support partners.
• Maintain accurate, complete laboratory records and facilitate electronic data and information gathering, capture, archiving, and communication techniques.
• Assist in preparation and review of manufacturing batch records, SOPs, and regulatory documentation as appropriate.

Qualifications

• Basic Qualification – PhD: PhD in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related discipline and 1–3 years of protein formulation and drug delivery development experience.
• Basic Qualification – Master’s: Master’s in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related discipline and 5–7 years of similar experience.
• Basic Qualification – Bachelor’s: Bachelor’s in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related discipline and 10 or more years of similar experience.

Preferred Qualifications

• Experience with both conventional and alternative biopharmaceutical protein formulation and drug product development, including DOE and other statistically based experimental design/interpretation approaches.
• Experience with protein product manufacturing processes and development (e.g., solution vial/PFS, lyophilization, container/closure assessment & selection), drug delivery feasibility, and compatibility evaluation.
• Experience with multiple bioanalytical and biophysical assessment techniques for product characterization and stability evaluation (HPLC, SDS‑PAGE/CGE, SEC, spectroscopy, DSC, particle analysis, capillary electrophoresis, etc.).
• Experience in authoring, contributing to, and critically reviewing successful regulatory submissions, particularly late clinical phase, BLA/MAA filings, and pre‑approval inspection experience.
• Experience with in‑vivo/in‑vitro models to assess formulation and delivery modalities.
• Experience in drug product manufacturing technology transfer to commercial scale or clinical scale-up would be beneficial.

Physical Demands & Working Environment

Employment requires remaining stationary more than 25% of the time, occasional movement within and outside laboratories, handling instruments and tools, lifting up to 25 pounds regularly and occasionally up to 100 pounds, and operating a computer and office machinery. Work is performed in laboratory settings requiring personal protective equipment and adherence to hazardous waste procedures.

Compensation

The annual compensation range for this full‑time position is $110,000 to $130,000, with final base pay determined by internal equity, location, and qualifications.

Equal Employment Opportunity

PerkinElmer is committed to creating a diverse environment and is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristic protected by applicable law.