Full Job Description
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:
Johnson & 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.
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 Research
