This job posting is anticipated to close on Mar 20 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:
Pharmacokinetics & PharmacometricsJob Category:
Scientific/TechnologyAll Job Posting Locations:
Spring House, 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 a Principal Scientist, Bioanalysis to be in Spring House, PA.
Purpose:
You will be responsible for:
- Developing robust sample preparation methods and LC-MS/MS methods to quantify drug candidates (small molecules and large molecules), metabolites, and endogenous biomarkers in biological matrices in support of non-clinical (GLP) studies.
- Troubleshooting assay or instrument issues and address bioanalytical challenges of complex assays by applying appropriate technology.
- Training lab scientists in becoming LC-MS experts over time.
- Executing method validation and sample analysis per departmental SOPs and industry guidance. Prepare or contribute to method report, assay validation protocol, validation report, and study report.
- Keeping accurate and timely documentation of electronic notebooks and study records per the requirements of SOPs.
- Coordinating with vendors for installation and operational qualification, computer system validation of LC-MS/MS instruments. Coordinate with service engineers for instrument maintenance and repair to minimize downtime. Handle service and repair documentation.
- Identifying, evaluating, and championing new technologies that will strengthen the lab capabilities in support of complex drug modalities while maintaining rigorous standards and compliance.
- Working in a regulated environment under limited supervision with a high level of autonomy and foster a collaborative and inclusive environment.
- Partnering closely with internal discovery lab, validation team, compliance team, and Principal Investigator to ensure the readiness of robust assays and data delivery timelines. Serve as a key contact for communicating technical information effectively across cross-functional teams.
Qualifications / Requirements:
Education:
- A MS degree in Analytical Chemistry, Biochemistry, or Biology with a minimum of 6 years of relevant industry experience or a Ph.D. degree in Analytical Chemistry, Biochemistry, or Biology with a minimum of 3 years of relevant industry experience is required.
Required:
- Experience in bioanalytical method development for the measurements of small molecules and large molecules using LC-MS/MS based technology, along with proven expertise in sample preparation techniques such as immunocapture, liquid-liquid extraction, protein precipitation, and solid phase extraction.
- Strong understanding of mass spectrometry and chromatographic separation. Hands-on experience in operating Sciex mass spectrometers (6500 or 7500 QTrap preferred) coupled with HPLC systems such as Shimadzu LC.
- Proficiency in liquid handling systems such as KingFisher, Agilent Bravo, Hamilton, Scinomix, etc.
- Proven track record of troubleshooting and successful development of hybrid immunocapture LC-MS/MS methods and working experience in complex modalities such as antibody-drug conjugates are preferred.
- In-depth knowledge of the principles of regulated bioanalysis and strong understanding of health authority guidance such as ICH M10 and GLP regulations.
- Proficiency in LIMS and ELN systems.
- Strong organizational skills and ability to prioritize projects and resources to meet delivery timelines. Strong verbal and written communication skills to effectively convey the plans and issues is required
Preferred:
- Experience in training scientific staff is preferred.
- Experience in regulatory submissions such as IND submission is preferred.
- Experience in endogenous analyte or biomarker is preferred.
- Knowledge of DMPK and experience in ligand binding assay (LBA) format are preferred.
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.
