Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director in the Analytical Resource Team (ART) of Large Molecule Analytical Develpment (LMAD), 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 Associate Director of analytical testing support will manage about 10 JnJ staff and 15 contractors in the ART of LM AD organization. The associate director will be responsible of leading a team to perform non-GMP and GMP testing in support of LM API and DPD process development DOE activities associated with early and later development products. In addition, the associate director will also support manufacturing process non-conformance investigations In this function the associate director fosters a collaborative culture with keen attention to customer needs. Additional responsibilities include but are not limited to the following:
- Represent the group in cross-functional project teams
- Create an environment that values innovation, leadership, scientific excellence, urgency and personal accountability.
- Share ownership of analytical methods that support NME’s
- Build strong relationship with other PDMS groups
- Provide analytical support and sample testing to LM API DPD process development on NMEs’ early and later phase development in a timely manner
- Analyzes data and highly complex situations involving the evaluation of tangible and identifiable variables to arrive at creative and effective solutions.
- Collaborating with other LM AD groups on method validation support.
- Provide analytical support to comparability studies and other desired studies as needed
- Communicate with other LM AD groups providing feedbacks on performance of methods used for sample testing to help the improvement of method development and optimization
- Manage analytical testing using external resources
- Provide analytical support to the manufacturing site(s) on process non-conformance investigations. Serves as an SME on the preparation of manufacturing site for health authority agencies’ inspections.
- MS in life science or related field with at least 10 years of experience in biotech industry OR a Ph.D. in life science or related field with at least 8 years of experience in biotech industry is required
- At least 8 years of people managing, as well as multi-project management experience is required
- Experience and knowledge with large molecule analytical development process and operation and analytical technology is required
- Hands on experience with analytical instruments such as HPLC, CE, plate readers, etc is preferred
- Experience with handling complexity and large volume of samples is required
- The candidate must have strong understanding of GMP, and ICH requirements
Janssen Research & Development, LLC. (6084)Job Function