iseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://https://www.janssenrnd.com for more information.
The Senior Associate Scientist, Bioassay Methods Development, will be responsible for the development of cell-based bioassays and binding assays to be used as Quality Control (QC) potency assays and in support of structure-function and biological characterization studies, to better understand mechanism of action for new molecular entities in clinical development and for commercial products. The individual will be accountable for method development, qualification, validation and transfer activities as well as the evaluation of new technologies.
Author protocols and reports. Perform and coordinate testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups.
Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP), safety, and environmental requirements. Ensure data integrity and protocol compliance.
Design, troubleshoot, and execute experiments independently. Analyze data, interpret results, and report data in laboratory notebooks. Collaborate with partners to troubleshoot assay problems as they occur. Maintain awareness of the current literature relevant to methods.
Write analytical sections of regulatory submissions. Support regulatory filings, including INDs and BLAs.
Provide technical support with development and QC laboratories and support Quality Assurance, Regulatory Affairs and Process Development groups for all phases of product development as well as ongoing support of analytical methods for marketed products.
A minimum of a Bachelor's degree in Biology, Pharmacology. Immunology, Biochemistry or a related scientific discipline is required. Master's degree in Biology, Pharmacology. Immunology, Biochemistry or a related scientific discipline is preferred.
A minimum of 4 years of relevant experience with a Bachelor's degree or a minimum of 2 years of relevant experience with a Master's degree is required.
Prior experience in the Biotechnology or Pharmaceutical industry (therapeutic proteins/antibodies, cell and gene therapies, and/or vaccines) is preferred.
Experience in the development of bioassays, binding assays, and/or immunochemical techniques is required.
Experience with cell culture is required.
Experience with aseptic technique is required.
Experience with flow cytometry is preferred.
Experience with Meso Scale Discovery (MSD) is preferred.
Experience with Biacore and/or other surface plasmon resonance technology is preferred.
Prior experience in a Good Manufacturing Practice (GMP) environment is preferred.
Experience with laboratory automation is preferred.
Experience with method robustness, Design of Experiments (DOE) and/or method design is preferred.
Familiarity with assay validation parameters is preferred.
Must have strong communication (verbal and technical writing) and interpersonal skills.
Must have the ability to communicate ideas and influence others is required.
The ability to operate effectively in a dynamic work environment and with cross-functional teams is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.