Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, located in Spring House, 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 Associate Director will lead a team responsible for process development for the cell therapy, gene therapy and/or viral vaccine processes within the API-Large Molecule group in Spring House, PA. He/she will lead a highly technical team to design and develop upstream (cell culture) and downstream purification manufacturing process at the laboratory and pilot-scale. The candidate will:
- Direct activities to develop drug substance process in a cross-functional matrix team, including the design of experiments, execution of the planned experiments, optimization of the process steps, and scale-up to the target process scale for early and late stage products
- Lead a team responsible for the design and execution of development studies to identify and determine appropriate ranges of (critical) process parameters for the drug substance process, to optimize titer, product production, and product quality
- Participate or take a lead role in a cross-functional team to transfer technology to cGMP manufacturing partners
- Write and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations
- Extensively collaborate with internal and external partners to evaluated and implement new process technologies
- Interact with internal cross-functional team members including QA, Regulatory, Legal, Operations and Discovery
- Work effectively in a team environment as well as contributing individually as well as managing the team to meet project timeline and objectives
- Other duties will be assigned, as necessary
A PhD in Chemical Engineering or Biological Sciences or Biochemistry with at least 7 years of relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry with at least 10 years of relevant experience OR a BS in Chemical Engineering or Biological Sciences or Biochemistry with at least 15 years of relevant experience is required
Prior industry experience and strong technical knowledge in the development of downstream purification processes for protein, antibodies, and/or virus based products are required
Scale-up of processes to pilot-scale and tech transfer to GMP manufacturing facility is required
Experience in process development with late-stage CMC, tech transfer, and BLA-authoring is preferred
Experience in managing and mentoring process scientists is required
Familiarity with the US and International regulatory guidelines in the biopharmaceutical industry is preferred
Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of biological products is preferred
Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
Experience with team-based collaborations or direct management of staff is required
Occasional domestic or international travel will be required
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function