Senior Scientist, Protein Formulations

Johnson & Johnson is recruiting for a Senior Scientist in Protein Formulations, Drug Product Development & Delivery located in Malvern, PA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The successful candidate will join a highly motivated team working within Drug Product Development & Delivery, and be responsible for leading and supporting the development of protein biotherapeutic drug products and delivery strategies as part of the broader CMC function.

Key Responsibilities:

• Devise and implement formulation and drug product presentation strategies to support all phases of clinical and commercial development
• Lead protein programs as a scientific integrator in early development
• Support late phase protein programs by leading formulation activities
• Design and execute studies to characterize, optimize, and demonstrate the stability of protein formulations through manufacturing, storage, transportation, and administration
• Provide subject matter expertise in interactions with health authorities, including authoring CTD granules, participating in meetings, and responding to questions

Qualifications

Qualifications

Education:

• Ph.D. in an appropriate scientific field such as Pharmaceutical Sciences, Biophysics, Chemistry, Bioengineering, etc. OR BS/MS with additional years of experience

Required:

• Knowledge of and experience with protein biophysical characterization techniques
• Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments
• Ability to identify protein liabilities and correlate protein behavior to data
• Technical writing skills, including the ability to maintain high quality documentation and prepare SOPs or other technical reports
• Ability to use emerging developments in relevant scientific fields to support new technical and research initiatives
• Communication and collaboration skills to both lead and work with teams
• Capability to learn and navigate problems with a high degree of independence

Preferred:

• Understanding of regulatory pathways for biotherapeutics. Experience with authoring and reviewing regulatory filings (e.g. IND, IMPD, BLA, MAA)
• Publication and presentation history and involvement with scientific organizations or conferences

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.