Senior Principal Scientist - MSAT Material Sciences (1 of 2)
Johnson & Johnson is hiring for a Senior Principal Scientist - MSAT Material Sciences (1 of 2)! This position will be located in Malvern, Pennsylvania; alternate work locations may be considered in Titusville, New Jersey or Horsham, Pennsylvania. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring efficient and effective manufacturing of our biopharmaceutical products? Apply now for this exciting chance to build and lead our MSAT Material Sciences team!
Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Large Molecule Drug Substance team, the MSAT Material Senior Principal Scientist will be responsible for management and optimization of raw materials and process contact materials to improve product quality, value and ensure regulatory compliance. They will partner with the MSAT Material Sciences Lead in building and institutionalizing the processes and tools to deliver raw material control strategies used in commercial supply chain.
Key Responsibilities:
- Owner of Lifecycle Management (LCM) raw material control strategy including supplier/material reliability, specification management, and critical material attribute monitoring
- Partner with MSAT drug substance and drug product operational teams for raw material-related manufacturing investigations and risk assessments
- Lead multidisciplinary product sub-team teams for raw material readiness in support of new product introduction, technical transfer, and commercial manufacturing operations
- Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
- Author, review, and approve raw material sections of regulatory documents for global filing updates of Janssen biotherapeutics drugs
- Leverage networking and influencing skills to ensure good collaboration with partners in MSAT, Therapeutic Development & Supply (TDS), Value Chain Management (VCM), Quality, and Regulatory
