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

Malvern, Pennsylvania, United States

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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

Protein Chemistry

Mass Spectrometry

Biologics CMC

Comparability Studies

Forced Degradation Studies

Product Characterization

Process Development

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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