Senior Principal Scientist, Bioanalytical Outsourcing

Johnson & Johnson Innovative Medicine•Spring House, PA

3d•Hybrid

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Senior Principal Scientist, Bioanalytical Outsourcing, located in Spring House, PA. Purpose: This is a scientific position within the Bioanalytical Discovery and Development Sciences (BDDS) group within the Preclinical Sciences and Translational Safety (PSTS) organization. This group is responsible for developing, validating, and conducting bioanalytical methods to support preclinical and clinical development of synthetic and biologic-based drugs. The primary focus for this position is to place and manage a set of assays at external organizations supporting GLP and clinical-stage programs, there may be some responsibility for discovery stage programs.

Requirements

PhD with 6+ years post-doctoral experience or Bachelor’s degree with 12+ years of working experience.
Knowledge of the drug development process from drug discovery to BLA/NDA license application.
Strong expertise and hands-on experience in the bioanalytical application of ligand binding assays including immunogenicity assays.
Strong expertise and hands-on experience with LC-MS/MS assays for small molecule and large molecule therapeutics.
Experience with managing bioanalysis for clinical trials and GLP preclinical.
The candidate will have a successful track record of problem solving, good organizational habits, excellent interpersonal skills, the ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.
Travel will be required, domestic and international, up to 20%.

Nice To Haves

Well versed with Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidance for bioanalytical method validation and immunogenicity assays.
The successful candidate will have excellent record keeping and communication skills.
Excellent interpersonal skills with the ability to interact effectively with people, internally and externally.
Detail‐oriented, with excellent organizational, record‐keeping, oral and written communication skills.

Responsibilities

Comprehensive oversight of all bioanalytical assays—including drug quantitation, immunogenicity (ADA and Nab), and soluble target engagement—across assigned programs and analytical platforms at external partners, ensuring seamless execution of bioanalytical activities from initiation through reporting.
Coordinate review process of the supply agreements, protocols, reports, regulatory filings as appropriate.
Ensure that all contractual obligations with external partners are met, including closely monitoring deliverables, timelines, cost, and quality standards as outlined in contracts.
Submit and track status of work orders and change orders through internal business systems.
Lead regular meetings with CRO labs to discuss bioanalysis progress, resources, reagent needs, issues, potential delays and communicate timelines and potential delays to J&J IM partners.
Ensure appropriate validation activities are planned and completed along with appropriate bioanalytical plans are implemented by CRO labs.
During study bioanalysis, review data on a daily/weekly basis from CRO labs.
Confirm sample analysis and data reporting schedules.
Troubleshoot issues related to the bioanalytical conduct of the study and find resolution in a timely manner so as not to affect reporting or submission timelines.
Communicate issues to partners with risks and mitigation strategies.
Collaborate with internal partners to prepare Data Transfer Agreements.
Coordinate sample tracking/sample management process.
Review central lab SOW to ensure sample shipping schedules are appropriate to J&J IM and/or CRO labs.
Verify appropriate samples are being shipped to J&J IM and/or CRO labs on a timely basis.
Assist in reconciliation of shipping and sample issues.
Verify appropriate samples are received by J&J IM and/or CRO labs for each analytical effort.
Track data reporting files when provided by CRO and review for accuracy in formatting and content.
Ensure all study reports are provided by CRO labs, sent to J&J for review and archival.
A portion of the responsibilities will be supporting programs in China. Candidate will be responsible for preparing shipping permits for study reagents and ensuring compliance with HGRAO guidelines.
Work with BDDS leadership to conduct onsite business reviews and scientific assessments of external CROs, evaluating partner laboratory capabilities and performance against BDDS standards and expectations.