Principal Scientist, Early Development ADSI

Johnson & Johnson Innovative Medicine • Malvern, PA

10d • Onsite

About The Position

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 providing strategic and technical leadership in analytical development and leading a cross-functional scientific team consisting of members from each of the AD sub-functions. This role will represent AD on the CMC team and be accountable for all AD project deliverables. The individual will lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs. They will also lead the analytical review of programs at governance meetings with support from subject matter experts and be accountable for the submission of complete, consistent, and high-quality regulatory documents to health authorities. Effective communication of project status/overview, resources, budget, and issues to senior management is crucial, as is accountability for project risk management, including the development of appropriate mitigation strategies and escalation to senior management. The role requires interaction with and influence on various stakeholders outside of Discovery, Product Development and Supply (DPDS), including Manufacturing, Regulatory, Quality, Discovery, and external partners.

Requirements

• A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline is required.
• 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.
• 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.

Nice To Haves

• A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline is preferred.
• A minimum of 2 years of experience working on cross-functional CMC teams or analytical sub-teams is preferred.

Responsibilities

• 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.

Benefits

• inclusive work environment
• respect the diversity and dignity of our employees
• recognize their merit
• Equal Opportunity Employer
• 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
• actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act
• commitment to providing an interview process that is inclusive of our applicants’ needs
• request an accommodation

What This Job Offers

• Job Type: Full-time
• Career Level: Principal