Principal Scientist, Bioanalytical Outsourcing

**Job Function**:
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function**:
Pharmacokinetics & Pharmacometrics
**Job Category**:
Scientific/Technology
**All Job Posting Locations**:
Beerse, Antwerp, Belgium

**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.

**We are searching for the best talent for a Principal Scientist, Bioanalytical 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.
- Review all proposed with key partners work prior to initiation
- Coordinate review process of the protocols/supply agreements/regulatory filings as appropriate
- Confirm all partners are satisfied with protocols/supply agreements/regulatory filing process.
- Implement contracts between J&J and external partners
- Ensure all appropriate legal approvals are obtained for planned studies
- Work with business operations, procurement and legal to settle study costs and ensure these are communicated and agreement with key partners
- Record and track status of purchase orders and changes orders in planning system
- Update status of projects as landmarks are reached
- Lead 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
- 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.
- Accountable for on-time delivery of bioanalytical data and reports to meet study and regulatory timelines.
- 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

**Qualifications / Requirements**:
**Education**:

- A PhD or Masters Degree with 5 years post-doctoral experience or a Bachelor of Science degree with a minimum of 10 years’ experience is required

**Required**:

- Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidances for bioanalytical method validation and immunogenicity assays is required

**Preferred**:

- Experience with clinical trials is preferred.
- Understanding of pharmacokinetics, immunogenicity assays and biomarkers is preferred.
- Attends in-house seminars and participates in scientific meetings as appropriate to support team goals is preferred
- Presents data and recommendations to outside consultants, at in-house research forums and at outside professional meetings preferred