Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Associate Scientist, 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 Senior Associate Scientist will be responsible for performing experimental studies within the Parentals and Liquid group in Drug Product Development related to the formulation development and testing of therapeutic proteins including monoclonal antibodies (Mab). Responsibilities include development and optimization of liquid and lyophilized formulations, as well as execution of characterization plans and stability studies. Additional responsibilities include but are not limited to the following:
- Designing and optimizing various formulation and filling unit operations including freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization, and overseeing the execution of pilot to commercial scale fill/finish manufacturing process
- Perform stability studies, using biochemical and biophysical properties, on experimental and target formulations; and will perform studies to evaluate the chemical and physical compatibility of formulations with container/closure components, manufacturing and administration equipment
- Perform technical analysis of the project data including trending of data
- Author technical reports and be involved with presentations of the data
- Follow general laboratory safety procedures, as related to biologically derived materials
- Collaborate with contacts inside the company including scientific staff as well as scientists in related functional areas such as Research, Process Sciences, Devices, QC/QA, Clinical, Manufacturing, Toxicology, Regulatory (CMC).
B.S. in an appropriate scientific discipline with at least 6 years of related laboratory experience OR a MS with at least 4 years laboratory experience OR a PhD with relevant experience is required
Demonstrated working knowledge in formulation and fill/finish process development for therapeutic products is preferred
Experience with characterization of biological molecules and development of analytical methodologies for characterization of drug product attributes is preferred
Working knowledge of numerous biochemical, biophysical and analytical methodologies such as HPLC, CD, fluorescence and UV spectroscopy, cIEF and cSDS, particle analyzers, etc. is required
Experience with aseptic process validation, scale up and technology transfer of liquid and solid dosage forms including lyophilization is preferred
Familiar with pharmacy procedures for drug preparation and human administration is preferred
Working knowledge of GLP or GMP requirements is preferred
Janssen Research & Development, LLC. (6084)Job Function