Principal Scientist, Formulations

Johnson and Johnson is recruiting for a Principal Scientist, Formulations in Drug Product Development & Delivery to be 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 Principal Scientist in the Drug Product Development & Delivery will be a lab-based role with expertise in protein science and support formulation development. The candidate will be an experienced individual contributor able to manage or contribute to scientific projects, programs, and processes. They will be responsible for the design and execution of experimental studies in pre-formulation, formulation and biophysical characterization of therapeutic proteins or other biologics including monoclonal antibodies (mAbs), multi-specifics, fusion proteins, and mixed conjugates. This includes development and optimization of the technical operations associated with liquid and lyophilized biologics development, diluent compatibility/administration relevant studies and stability campaigns.



Key Responsibilities:

• Design, complete, analyze, and document studies to develop and optimize formulations for biologic therapeutics. Studies include, but are not limited to, biophysical characterization, stability, composition selection, robustness, and development of administration protocols.
• Plan, conduct, evaluate, and record studies to support formulation selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, and mixing.
• Design, complete, analyze, and document compatibility studies to support administration of biologic therapeutics.
• Clearly and effectively communicates, plans, results and decisions to key partners and broader team.
• Accurately interpret complex datasets and effectively communicate impact through formal and informal disclosures.
• Develop technologies and use new developments in emerging fields to improve processes, formulations, drug delivery strategies and generate innovative research ideas.

Qualifications

Education:

• A minimum of a Bachelor's degree with 6+ years of relevant experience (in an appropriate scientific field such as Biomedical engineering, Chemical Engineering, Pharmaceutical Sciences, Biophysics, Chemistry, etc.) is required.
• An advanced degree (Master's degree with 4+ years or PhD with 2+ years of relevant experience) is preferred.

Experience and Skills:

Required:

• Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required.
• Ability to use emerging developments in relevant scientific fields to support new technical and research initiatives is required.

Preferred:

• A strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization is preferred.
• Experience with protein biophysical characterization and chromatography techniques such as HPLC, fluorescence and UV spectroscopy, light scattering (e.g. SLS, DLS), particle analysis (e.g. MFI, HIAC), and separation methods (e.g. CEX, cIEF, HIC) is preferred.
• Ability to identify protein liabilities and perform developability assessments for products from pre-clinical to commercial readiness is preferred.
• Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments is preferred.
• Experience in protein formulation and drug product development including high throughput screening, biophysical characterization, computational modeling and advanced data analytics is preferred.
• Understanding of regulatory pathways for large molecule therapeutics is preferred.
• Experience with authoring and reviewing regulatory filings supporting IND, IMPD, BLA, or MAA is preferred.
• Proven publication and presentation history and involvement with scientific organizations or conferences is preferred.

This job posting is anticipated to close on 11/04/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.