What are the responsibilities and job description for the Scientist, Large Molecule Drug Product Development & Delivery position at Johnson & Johnson?
Janssen Research & Development, LLC., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Large Molecule Drug Product Development to be located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The 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 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 implement studies to support formulation selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing,
- Design and complete 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
Required:
- Ph.D. in an appropriate scientific subject area such as Pharmaceutical Sciences, Biophysics, Chemistry, etc. or an MS with 3 years of experience
- Strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization.
- 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)
- 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:
- Experience in computational biophysics, modeling and sophisticated data analytics to support large molecule drug product development
- 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.
