Senior Scientist, Formulations

Location: Malvern

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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.

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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:

• Devising and implementing formulation and drug product presentation strategies to support all phases of clinical and commercial development
• Leading protein programs as a scientific integrator in early development
• Supporting late phase protein programs by leading formulation activities
• Designing and executing studies to characterize, optimize, and demonstrate the stability of protein formulations
• Providing subject matter expertise in interactions with health authorities, including authoring IND granules, participating in meetings, and responding to questions

Qualifications/Requirements:

Education:

• Pharm
  
  D 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:

• Fundamental biophysics background, with expertise in the kinetics of protein folding and unfolding, reversibility, stability, and formulation selection
• Fundamental biophysics background, with expertise in the kinetics of protein folding and unfolding, reversibility, stability, and formulation selection
• Knowledge of and experience with protein biophysical characterizations techniques
• Experience interpreting and analyzing data from biophysical and biochemical assays and designing appropriate experiments
• 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:

• Demonstrated expertise in designing, building, and optimizing appropriate stability models
• 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…