Principal Scientist, Early Development ADSI

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 jnj.com.As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.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:About Innovative MedicineOur 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 & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, Early Development ASDI located in Malvern, PA.The Principal Scientist, Early Development Analytical Development Scientific Integrator (ADSI) will be responsible for the following:Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.Represent AD on the CMC team and accountable for all AD project deliverables.Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.Lead the analytical review of programs at governance meetings with support from subject matter experts.Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.Effectively communicate project status/overview, resources, budget, and issues to senior management.Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.Interact with and influence various stakeholders outside of Discovery, Product Development and Supply (DPDS), including Manufacturing, Regulatory, Quality, Discovery, and external partners.Qualifications:A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline in preferred.A minimum of 6 years of experience in biopharmaceutical development with a Master’s degree or a minimum of 3 years of experience in biopharmaceutical development with a Ph.D. is required.A minimum of 2 years of experience working on cross-functional CMC teams or analytical sub-teams is preferred.Knowledge of biotherapeutic development and analytical strategies, including analytical protein characterization, separation techniques, and biological potency assays, is required.Experience authoring and reviewing CMC sections of clinical trial applications (INDs/IMPDs) and addressing health authority questions is required.Must have excellent communication, interpersonal and negotiation skills.Must have strong leadership skills.The ability to collaborate across teams in a matrix environment is required.The ability to lead and execute complex plans/deliverables in a matrix environment is required.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 and 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, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource.Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific ResearchSummaryLocation: Malvern, Pennsylvania, United States of AmericaType: Full time