Senior Scientist, Formulations at Johnson & Johnson

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Biotherapeutics R&DJob Category:Scientific/TechnologyAll Job Posting Locations:Malvern Pennsylvania United States of AmericaJob 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 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 developmentLead protein programs as a scientific integrator in early developmentSupport late phase protein programs by leading formulation activitiesDesign and execute studies to characterize optimize and demonstrate the stability of protein formulationsProvide subject matter expertise in interactions with health authorities including authoring IND granules participating in meetings and responding to questionsQualifications/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 techniquesExperience interpreting and analyzing data from biophysical and biochemical assays and designing appropriate experimentsFamiliarity with clinical practices and compendial guidance for preparation and administration of parenteral drug products in the clinical trial and commercial settingAbility to innovate and use emerging developments in relevant scientific fields to support new technical and research initiativesTechnical writing skills including the ability to maintain high quality documentation and prepare SOPs or other technical reportsCommunication and collaboration skills to both lead and work with teamsCapability to learn and navigate problems with a high degree of independencePreferred: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 conferencesJohnson & 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 internal employees contact AskGS to be directed to your accommodation resource.#LI-HybridRequired Skills: Preferred Skills:Required Experience:Senior IC Key Skills Laboratory Experience,Mammalian Cell Culture,Biochemistry,Assays,Protein Purification,Research Experience,Next Generation Sequencing,Research & Development,cGMP,Cell Culture,Molecular Biology,Flow Cytometry Employment Type : Full-Time Experience: years Vacancy: 1