Description
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:
Schaffhausen, SwitzerlandJob Description:
Principal Lead, MST & Ext Manufacturing
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.
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 Description:
About Innovative Medicine
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.
The Principal Lead, MST & External Manufacturing will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with a focus on Parenterals. You will represent the DPDS in development and clinical/commercial supply teams ensuring timely clinical supplies for drug products and you will manage the relationship from technical point of view with the CMOs.
Key Responsibilities:
Ensure timely readiness of contract manufacturing organizations (CMO) or JnJ internal pilot plant to support clinical activities.
Ensure timely delivery of clinical material from CMO and/or JnJ internal pilot plant.
Manage the overall relationship with CMOs and act as the single point of contact between the organization and the respective manufacturing site.
Provide input and requirements to drug product development and primary container development teams.
Support scale-up and technology transfer.
Source raw materials and components and act as point of contact for material and supplier-related issues at CMO.
Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations.
Support investigations, CAPAs, change controls according to assigned responsibilities and perform critical raw data review for key documents.
Identify opportunities for process optimization and drive continuous improvement initiatives
Prepare business plan forecasts and monitor actual spending versus budget.
Qualifications
Education:
A minimum of a Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related field with 8+ years of relevant biopharmaceutical experience, including 8+ years of sterile drug product process development and manufacturing experience; or a Master's degree with 6+ years; or a PhD with 4+ years is required.
Experience and Skills:
Required:
Demonstrated proficiency and experience in biopharmaceutical process design is required.
Understanding and experience in fill/finish operations is required.
Experience in clinical or commercial manufacturing is required.
Motivated with the ability to work independently with demonstrated problem solving skills is required.
Ability to collaborate with cross-functional teams is required.
Prior experience working with a CMO is required.
Excellent English and German oral and written language skills are required.
Good CMO relationship management skills
Good understanding of procurement and legal workflows needed to support contract negotiations and new CMO onboarding
Preferred:
Proven proficiency and experience in biologics drug product development within the biopharmaceutical industry is preferred.
Solid understanding and experience in technology transfer operations is highly preferred.
Proven track record of creativity and problem solving skills highly preferred.
#DPDS
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