This job posting is anticipated to close on Mar 19 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Malvern, Pennsylvania, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Senior Scientist, Bioassay Methods Development, to be in Malvern, PA.
Purpose:
The Senior 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.
You will be responsible for:
- 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 / Requirements:
Education:
- A minimum of a Bachelor's degree in Biology, Pharmacology. Immunology, Biochemistry, or other relevant scientific field, with at least 7 years of industry experience, a Master's degree with at least 5 years of industry experience, or a PhD with 0-3 years of relevant experience is required.
Required:
- Experience in development of bioassays, binding assays, and/or immunochemical techniques.
- Experience with cell culture and aseptic technique.
- The ability to communicate ideas and influence others is essential.
- Strong technical writing and verbal communication skills.
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment.
Preferred:
- Experience with flow cytometry.
- Experience with Biacore and/or other surface plasmon resonance technology.
- Experience with automated liquid handlers (e.g. Tecan or Hamilton).
- Prior experience in the biotechnology or pharmaceutical industry (therapeutic proteins/antibodies, cell and gene therapies, and/or vaccines).
- Prior experience in a GMP environment and experience with laboratory automation.
- Preferred skills would include method robustness, DoE, method design, and familiarity with assay validation parameters.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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