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We are searching for the best talent for a Senior Scientist, Protein Characterization (Forced Degradation Studies) to be in Malvern, PA.

Purpose:

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.

You will be responsible for:

• Perform protein forced degradation studies and characterize degradation pathways
• Identify PTM CQAs through structure/function studies
• Perform serum stability studies for ADC products
• 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 / Requirements:

Required:

• Bachelor’s Degree or Master’s Degree in Analytical Chemistry, Biochemistry, Biotechnology, Protein Formulations, Chemical Engineering, or a related field with 4-6 years of experience is required; OR a PhD in Analytical Chemistry, Biochemistry, Biotechnology, Protein Formulations, Chemical Engineering, or a related field with a minimum of 0-2 years of experience following the completion is highly preferred.
• Strong knowledge of protein chemistry and characterization experience with protein characterization with mass spectrometry and liquid chromatography
• 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 protein forced degradation studies
• Experience with characterization of antibody drug conjugates (ADCs)
• Experience working with protein serum stability studies
• 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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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