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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.
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Worksite address
collegeville, PA, 19426, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.