Senior Scientist, Protein Characterization (Forced Degradation Studies) at Johnson & Johnson

Malvern, Pennsylvania, United States

Johnson & Johnson Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

  • 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; 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 completion (PhD highly preferred)
  • Strong knowledge of protein chemistry and characterization experience with protein characterization using 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 Requirements
  • 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

Responsibilities

  • 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
  • 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
  • Develop, design, and perform mass spectrometry assays in support of product characterization and process development activities

Skills

Key technologies and capabilities for this role

Protein ChemistryMass SpectrometryBiologics CMCComparability StudiesForced Degradation StudiesProduct CharacterizationProcess Development

Questions & Answers

Common questions about this position

What is the salary for this Senior Scientist position?

This information is not specified in the job description.

Is this role remote or onsite, and where is it located?

The position is located in Malvern, PA at 200 Great Valley Pkwy, with no mention of remote work options.

What qualifications and skills are required for this role?

A Bachelor’s or Master’s Degree in Analytical Chemistry, Biochemistry, Biotechnology, Protein Formulations, Chemical Engineering, or related field with 4-6 years of experience is required; a PhD in these fields with 0-2 years is highly preferred. Strong knowledge of protein chemistry and characterization experience is also required.

What does Johnson & Johnson’s company culture emphasize?

The company focuses on healthcare innovation to prevent, treat, and cure complex diseases, with expertise in Innovative Medicine and MedTech, championing patients and developing life-saving medicines.

What makes a strong candidate for this Senior Scientist role?

Candidates with a PhD in Analytical Chemistry, Biochemistry, or related fields and experience in protein chemistry, forced degradation studies, mass spectrometry, and GMP compliance will stand out.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters
1886Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.
Former J&J executives joining other firms could lead to increased competition.
Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.
The company invests heavily in R&D for innovative medical solutions and products.
J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.
The rise of personalized medicine offers J&J opportunities in targeted therapies.
Increased focus on digital health solutions presents expansion opportunities for J&J.

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