Principal Scientist

Scorpion Therapeutics; Collegeville (PA); On-site; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Scientist in sterile drug product development to lead biopharmaceutical protein (e.g., mAbs, bispecific mAbs, ADCs) and peptide drug product development for Clinical Phases 2–3 and commercialization.

You will perform laboratory experiments, develop non-GMP formulation optimization and stability studies, support process development and tech transfer to GMP manufacturing, and author technical and regulatory documents with precise electronic records.

Qualifications

• PhD with 0+ years protein formulation and/or process development; or MS with 5+ years industry experience; or BS with 7+ years industry experience.
• Experience authoring technical documents.

Responsibilities

• Lead matrix collaboration to progress drug product development.
• Perform laboratory experiments using biophysical techniques.
• Conduct non-GMP formulation optimization and stability studies.
• Assess in-use compatibility and stability for product administration.
• Support drug product process development and tech transfer to GMP.
• Author technical and regulatory documents and maintain electronic records.
• Use electronic data gathering, archiving and communications.
• Contribute to small-molecule development when applicable.

Skills

Protein formulation

Process development

DOE design

Biophysical characterization

Regulatory document authoring

Education

PhD in Pharmaceutical Sciences / Chemistry / Biochemistry / Biology / Bioengineering / Biomedical / Chemical Engineering

MS with 5+ years industry experience

BS with 7+ years industry experience

Job description

Position Summary:

Scientist in sterile drug product development focused on leading biopharmaceutical protein (e.g., mAbs, bispecific mAbs, ADCs) and peptide therapeutics drug product development for Clinical Phases 2–3 and commercialization.

Role Responsibilities:

• Matrix leadership and cross-department collaboration to progress drug product development.
• Laboratory experimentation using biophysical techniques.
• Conduct non-GMP protein formulation optimization and development stability studies.
• Perform in-use compatibility/stability assessments to support product administration.
• Support drug product process development, characterization, and technical transfer to GMP manufacturing.
• Author technical and regulatory documents; maintain accurate, complete electronic laboratory records.
• Use electronic data/information gathering, capture, archiving, and communications.
• Potential contribution to small-molecule drug product development (e.g., chemical entities, oligonucleotides).

Basic Qualifications (Required):

• PhD in Pharmaceutical Sciences/Chemistry/Biochemistry/Biology/Bioengineering/Biomedical/ Chemical Engineering with 0+ years protein formulation and/or process development; or MS with 5+ years industry experience; or BS with 7+ years industry experience.
• Experience authoring technical documents.

Preferred Qualifications:

• ADC experience.
• Bioanalytical interpretation for characterization and stability.
• Conventional/alternative protein formulation stability evaluation using DOE/statistical experimental design.
• Protein drug product process development (e.g., vial/PFS solution, lyophilization), container/closure and drug-delivery feasibility/compatibility.
• Biophysical characterization/stability (e.g., DSC, DSF/Uncle/Prometheus Panta, particle sizing, light scattering).
• Regulatory document authoring and critical review (IND/IMPD, BLA/MAA), especially late clinical phase; regulatory Q&A.
• Manufacturing technology transfer to commercial and/or scale-up.
• Experience with biopharm combination products.
• Strong independent and team/matrix communication; accurate lab records and electronic data management.