Johnson & Johnson Careers

Associate Scientist, Drug Product Development Large Molecules

Malvern, Pennsylvania
R&D


Job Description

Requisition ID: 2640190423

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an 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.

Within Biotherapeutics Drug Product Development (DPD) department we are offering an opportunity for an Associate Scientist. The Associate Scientist will be responsible for performing experimental studies related to process improvement and quality compliance efforts as it relates to formulation/process development and testing of therapeutic proteins, monoclonal antibodies (mAbs), gene therapy and CAR-T related compounds. This includes the development and optimization of the technical operations associated with liquid and lyophilized biologics formulations/processes, as well as execution of pharmacy manual plans and stability studies. Additional duties and responsibilities include but are not limited to the following:

• Development and optimization of liquid and lyophilized biologics formulations, as well as execution of characterization plans and stability studies
• Designing and optimizing various formulation and filling unit technical operations including freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization
• Participate in overseeing the execution of pilot fill/finish manufacturing processes.
• Design and manage non-GMP stability studies on experimental and target formulations
• Perform studies that contribute to the continuous improvement manufacturing process, and administration equipment
• Perform technical analysis of the project data, including trending of data, and may be expected to present data to peers and functional management
• Author technical reports and make presentations of technical data
• Follow general laboratory safety procedures, as related to biologically-derived materials
• Collaborate with contacts inside the company including functional line management as well as scientists in related functional areas such as Research and Development, QC/QA, Clinical, Manufacturing, Toxicology, and Regulatory (CMC)
• Perform her/his duties consistent with good laboratory practices


Qualifications
• B.S. in an appropriate scientific discipline with at least 3 years of related laboratory experience OR an M.S. with at least 1-2 years laboratory experience is required
• Pharmaceutical and/or Biotechnology experience is preferred
• Experience with formulation and fill/finish process development for therapeutic protein and/or biologic products (Gene Therapy/CAR-T) is preferred
• Working knowledge of GLP and GMP requirements are preferred
• Experience with characterization of biological molecules is preferred.
• Working knowledge of biochemical, biophysical and/or analytical methodologies (i.e.: HPLC, fluorescence and UV spectroscopy, particle analyzers, etc.) is preferred
• Experience with aseptic tissue culture techniques and handling of gene therapy/CAR-T related compounds is required.
• Familiarity with pharmacy procedures for drug preparation and human administration is preferred
• This role is based in Malvern, PA and may require up to 5% of domestic travel.


Primary Location
United States-Pennsylvania-Malvern-
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
2640190423