Johnson & Johnson Innovative Medicine is recruiting for an Associate Scientist in Bioassay Methods Development located in Malvern, PA.
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The Associate Scientist, Bioassay Methods Development, will be responsible for the development of cell-based bioassays and binding assays to be used as 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.
Key Responsibilities:
- Authoring protocols and reports. Performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
- Accurately recording data in a timely manner, including maintenance of detailed records in compliance with applicable GMP, safety, and environmental requirements. The successful candidate will ensure data integrity and protocol compliance
- Designing, troubleshooting, and executing experiments independently. Analyzing data, interpreting results, and reporting data in laboratory notebooks. Collaborate with partners to troubleshoot assay problems as they occur. Maintain awareness of the current literature relevant to methods
- Writing analytical sections of regulatory submissions is encouraged. The Scientist will support regulatory filings including INDs and BLAs
- Providing technical support with development and QC laboratories is expected and the successful candidate will also 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
Qualifications
Education:
- A minimum of a Bachelor's degree in Biology, Pharmacology. Immunology, Biochemistry, or other relevant scientific field is required
Experience and Skills:
Required:
- A minimum of 2 years industry experience, or a Master's degree with at least 1 year of industry experience or relevant academic experience is required
- Experience in development of bioassays, binding assays, and/or immunochemical techniques is required
- Experience with cell culture and aseptic technique is required
- Strong technical writing and verbal communication skills are required
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment are required
Preferred:
- The ability to communicate ideas and influence others is preferred
- Experience with flow cytometry is preferred
- Experience with Biacore and/or other surface plasmon resonance technology is preferred
- Prior experience in the biotechnology or pharmaceutical industry (therapeutic proteins/antibodies, cell and gene therapies, and/or vaccines) is preferred
- Prior experience in a GMP environment and experience with laboratory automation is preferred
- Preferred skills would include method robustness, DoE, method design, and familiarity with assay validation parameters
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com