Senior Scientist, Scientific Outsourcing

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 Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Spring House, Pennsylvania, United States of America

Job 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 Senior Scientist, Scientific Outsourcing to be 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 small molecule 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.

You will be responsible for:

• Complete oversight of the bioanalytical assays (pharmacokinetics, immunogenicity and soluble target engagement)
• Oversight of all bioanalytical-related activities across assays and platforms for assigned programs at external partners. Ensure smooth conduct from initiation to reporting
• Reviewing all proposed with key partners work prior to initiation
• Coordinating review process of the protocols/supply agreements/regulatory filings as appropriate
• Confirming all partners are satisfied with protocols/supply agreements/regulatory filing process
• Implementing contracts between J&J and external partners
• Ensuring all appropriate legal approvals are obtained for planned studies
• Working with business operations, procurement and legal to settle study costs and ensure these are communicated and agreement with key partners
• Applying internal systems to submit work orders and change orders
• Recording and tracking status of purchase orders and changes orders in planning system
• Updating status of projects as landmarks are reached
• Leading regular meetings with CRO lab(s) to discuss bioanalysis progress, resources, reagent needs, issues, potential delays and communicate timelines and potential delays to J&J IM partners
• Ensuring appropriate validation activities are planned and completed along with appropriate bioanalytical plans are implemented by CRO labs
• During study bioanalysis, reviewing data on a daily/weekly basis from CRO labs. Confirming sample analysis and data reporting schedules
• Troubleshooting 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. Communicating issues to partners with risks and mitigation strategies
• Collaborating with internal partners to prepare Data Transfer Agreements
• Coordinating sample tracking/sample management process
• Reviewing central lab SOW to ensure sample shipping schedules are appropriate to J&J IM and/or CRO labs
• Verifying appropriate samples are being shipped to J&J IM and/or CRO labs on a timely basis
• Assisting in reconciliation of shipping and sample issues
• Verifying appropriate samples are received by J&J IM and/or CRO labs for each analytical effort
• Accountable for on-time delivery of bioanalytical data and reports to meet study and regulatory timelines
• Tracking data reporting files when provided by CRO and review for accuracy in formatting and content
• Ensuring 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

Qualifications / Requirements:

Education:

• A minimum of a Bachelors of Science degree is required
• A Masters degree is preferred

Required:

• A minimum of 8 years relevant experience is required. This can include post-doctoral experience
• Knowledge of the drug development process from drug discovery to BLA/NDA license application is required
• Strong expertise in the bioanalytical application of ligand binding assays including immunogenicity assays is required
• Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidances for bioanalytical method validation and immunogenicity assays is required
• 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
• Attending in-house seminars and participating in scientific meetings as appropriate to support team goals is required
• Presenting data and recommendations to outside consultants, at in-house research forums and at outside professional meetings is required

Preferred:

• Experience with clinical trials is preferred
• Understanding of pharmacokinetics, immunogenicity assays and biomarkers is 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.