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/.
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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.