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SalaryJanssen Research & Development, LLC., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Large Molecule Drug Product Development to be located in Malvern, PA.
About Johnson & Johnson
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/.
The Senior Scientist in the Large Molecule Drug Product Development will be a lab-based role with expertise in protein science to support formulation development. The candidate 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), bispecifics, 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 (pharmacy manual) stability campaigns.
Key Responsibilities :
- Design and execute 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.
- Design and execute studies to support formulation selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing,
- Design and execute compatibility studies to support administration of biologic therapeutics
- Collect, analyze, and interpret data appropriately.
- Author technical reports and present data to peers and functional management.
Qualifications
- PharmD or Ph.D. in an appropriate scientific discipline such as Pharmaceutical Sciences, Biophysics, Chemistry with a minimum of 3 or more years of experience, or an MS with a minimum of 6 or more years of experience is required.
- For Ph.D.: Strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization.
- For Ph.D.: 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)
- For PharmD: Experience and familiarity with various pharmacy preparation and clinical administration techniques, norms, and product design consideration
- Ability to identify protein liabilities and perform developability assessments for products from pre-clinical to commercial readiness.
- Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments
- 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.
Preferred:
- Understanding of regulatory pathways for Large Molecule therapeutics. Experience with authoring and reviewing regulatory filings supporting IND, IMPD, BLA, or MAA.
- Proven 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.
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.
