Principal Scientist

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 https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Greenville, North Carolina, United States, Malvern, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

Apply today for this exciting opportunity to be part of our growing team!

Remote work options may be considered on a case-by-case basis and if approved by the Company in the North Carolina, Greenville area

As a Principal Scientist in Global MSAT your primary role is as Technical Owner (TO), with specific responsibility for significant program/brand. The TO is the voice of MSAT in the Value Chain Team and responsible for the technical aspect of the Lifecycle Management structure and strategy of DP during their commercial lifespan.

Key Responsibilities:

• Represents MSAT and the technical team in the Value Chain Team (VCT) and provides the required manufacturing technical support

• Participates in the VCT to develop the long-term supply strategy including scenario development and E2E impact analysis

• Supports the VCT to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)

• Coordination of all product-related technical activities

• Supervises technical process and product performance

• Identifies and implements opportunities for active decrease in manufacturing COG’s

• Implements or follows-up on execution of technical projects

• Deploys the platform standardization policy as appropriate

• Supports failure investigations (escalation of quality or compliance events)

• Reviews technical product & process risk profile and criticality analysis

• Implementing and supporting new platforms innovations or changes in life cycle management products

• Provides this expertise as well to External Manufacturing related to the Biotherapeutics Platform

Qualifications

Education:

• A minimum Bachelor’s degree is required

Experience and Skills:

Required:

• A minimum 8 years of relevant experience and BS degree or equivalent OR 5+ years with advanced degree MS/MBA/Ph.D. or equivalent.

• Experience of process validation. Preferably in the field of large molecule Drug Product.

• Prior experience leading Tech Transfer- and Launch activities (Internal or external partners)

• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations

• Manufacturing experience within a GMP regulated environment

• Excellent interpersonal and communication skills

• Shown leadership in providing integration of activities and information across multifunctional groups and matrix teams

• Knowledge of technical aspect of the lifecycle strategy of products

• Science-based risk approach and regulatory intelligence experience

• Ability to influence and lead peers, superiors, and external partners.

Preferred:

• Experience in Life Cycle Management, DP development and project management.

• Document Mgmt. systems such as TruVault, etc. SAP, MS Office applications, TrackWise, Planisware, MS-project, Minitab or similar statistical software