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

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for our Senior Scientist, Formulations located in Malvern, PA.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose: The Sr. Scientist, Formulations 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.

You will be responsible for:

• 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
• Provide subject matter expertise in interactions with health authorities, including authoring IND granules, participating in meetings, and responding to questions

Qualifications/Requirements:

Education:

• PharmD or PhD with 0-3 years (or BS or MS with >3 years) of clinical or industry experience is required. Pharmaceutical industry experience preferred.

Experience and Skills:

Required:

• Knowledge of and experience with protein biophysical characterizations techniques
• Experience interpreting and analyzing data from biophysical and biochemical assays and designing appropriate experiments
• Familiarity with clinical practices and compendial guidance for preparation and administration of parenteral drug products in the clinical trial and commercial setting
• Ability to innovate and use emerging developments in relevant scientific fields to support new technical and research initiatives
• Technical writing skills, including the ability to maintain high quality documentation and prepare SOPs or other technical reports
• 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 or clinical organizations or conferences

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

 

 

Preferred Skills: