Janssen Research & Development, LLC, a division of Johnson & Johnson's Family of Companies is recruiting for an Head of Large Molecule Drug Product Development, located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/
for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The job holder has overall responsibility for leading the Global Large Molecule Drug Product Development (DPD) organization for Janssen Pharmaceutical Development and Manufacturing Sciences. This covers drug product and process development, developing content for regulatory submissions, due diligence for L&As as well as overall responsibility for managing all aspects of the DPD sub-stream within the Large Molecule Value Stream for early and late development as well as Janssen Supply Chain lifecycle management support. The job holder sets the overall development strategy for Drug Product Development covering continuous scientific and technology advancement, benchmarking, and evolving strategy with respect to regulatory and healthcare expectations and strategy in relation to sourcing and geographic footprint. Additionally, the job holder has the responsibility for staffing and budgeting for his organization. As part of the Large Molecule Value Stream leadership team (covering API-LM, Drug Product, Analytical Development, and Portfolio Management) the job holder plays a substantive role in defining and shaping the long-term business strategy for Large Molecule Development.
Additional responsibilities include but are not limited to:
- Leading and directing a diverse group of scientists & engineers responsible for developing drug product formulations and drug product manufacturing processes for Large Molecule and Peptide NMEs in support of new and existing commercial products and processes
- Influencing across disciplines with senior leaders and external colleagues/ partners to drive and align strategic and operational scientific activities across regions, therapeutic/functional areas
- Ensures GxP compliance as needed in drug product development laboratories
- Ensures staff are properly trained for their roles in drug product development organization
- PhD in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or equivalent with at least 10 years of overall post graduate work experience is required
- Significant expertise in Biopharmaceutical Dosage Forms, Drug Delivery systems and the overall drug development process is required
- Demonstrated experience and positive track record in multiple R&D or Commercial disciplines is required
- Experience in early stage, late stage, and/or lifecycle management large molecule drug product and manufacturing process experience is required
- Monoclonal antibodies, bispecific antibodies, and fusion proteins is preferred
- Parenteral drug product development and technical transfer for liquid and lyophilized drug product manufacturing is preferred
- Pharmacy manual supportive studies supporting in–use of products at clinical sites including low dose drug products is preferred
- Familiar with GxP compliance is preferred
- Familiar with ICH regulatory guidelines is preferred
- IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience for biologics is preferred
- Demonstrated people management and matrix team leadership experience with a proven track record of directly leading complex scientific team(s) and core technical leaders and managers of managers across functions/regions for an extended period of time is required
- 20-30% international and domestic travel is required
Janssen Research & Development, LLC. (6084)Job Function