SENIOR SCIENTIST, CMC COMPARABILITY

Janssen Research & Development, L.
.
., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, CMC Comparability located in Malvern, PA.
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The Senior Scientist will apply an understanding of protein chemistry and characterization to drive comparability studies in the context of the chemistry, manufacturing, and controls (CMC) requirements for biologics.
Specifically, the candidate will coordinate all aspects of comparability studies resulting from drug substance and drug product process changes for new molecular entities in clinical development or for commercial products.
The successful candidate will also develop, design, and perform mass spectrometry assays in support of product characterization and process development activities.
Primary responsibilities.
Write protocols, reports, and coordinate testing across functional groups.
Effectively communicate comparability plans and results to management review committees and representation on cross-functional project teams.
Write analytical sections of regulatory submissions.
Design and execute LC/MS assays for characterizing antibody and non-antibody products (mAb and non-mAb products).
Maintain laboratory notebooks and prepare written protocols and reports in a Good Manufacturing Practice (GMP) compliant manner.
Qualifications Education.
Bachelor’s degree is required Master’s degree or PhD is highly preferred Required.
Minimum of 10 years of experience following the completion of a Bachelor’s Degree OR minimum of 5 years of experience following the completion of a Master’s Degree OR minimum of 0-2 years of experience following the completion of a PhD in Analytical Chemistry, Biochemistry, Biotechnology, Protein Formulations, Chemical Engineering, or a related field Strong knowledge of protein chemistry and characterization experience with protein physicochemical characterization methods (reverse-phase, ion-exchange, size-exclusion HPLC, cSDS/SDS-PAGE, cIEF/IEF, mass spectrometry, CD, AUC, or DSC) Hands-on experience with Mass Spectrometry Experience working in a GLP/GMP environment Experience performing and managing complex studies Ability to balance and contribute to multiple project priorities Ability to independently work across other functions (regulatory, QC, process development) to drive studies Good written and verbal communication skills Preferred.
Experience performing comparability studies or characterization studies to establish biosimilarity Experience with characterization of antibody drug conjugates (ADCs) Experience working with protein stability studies for comparison of degradation profiles Experience with LC/MS peptide mapping methods and analysis software to identify and quantitate post-translational modifications Experience and understanding of pharmaceutical development chemistry, manufacturing and controls (CMC) processes and regulatory requirements for protein biologics Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.