Scientist, Bioanalytical Integrator

Job Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Bioanalytical Integrator located in Spring House, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Scientist, Bioanalytical Integrator will serve as a primary point of BAS contact for interactions with internal JBIO functional teams (including Project Management, Trial Support and Laboratory Support) and clinical customers [including Clinical Pharmacology and Pharmacometrics (CPP), clinical teams (CTs), cross-functional trial teams (CFTTs), Compound Development Teams (CDTs) and Chemistry, Manufacturing & Controls (CMC) teams] to ensure two-way communication of information necessary for delivering a single BAS regulatory submission-related project.

Responsibilities will be focused on a single regulatory submission-related project, but are not limited to, the following:

• Serve as single point of contact for Cross Functional Trial Teams (for internal work) or to the appropriate partner representatives for collaborative studies (for external work), Project Managers and Compound Development Team (CDT) for bioanalytical related questions, concerns, issues, timelines, etc.
• Be accountable for on-time delivery of bioanalytical data and reports to meet study and regulatory timelines.
• Work with partners to ensure full understanding of bioanalytical process
• Review all supply agreements, study protocols and regulatory submissions pertaining to sampling and bioanalytical testing for PK, ADA, NAb, RO, and sTE, central lab SOWs, Data Flow diagrams, and Laboratory Manuals.
• Communicate updates on immunoassay development, validation, bioanalysis, and technical issues to external stakeholders but when complex scientific questions arise, invite BDS functional area leads ad hoc to discuss scientific issues.
• Manage CPP and CFTT expectations: communicate well across internal functions (e.g. sample management, data flow, and central laboratory operational support functions), and external teams on potential risks and mitigation plans; business partners on the regulatory requirements adhered to by BAS; participate in efficient strategy design related to PK/ADA data generation and the supporting information including but not limited to: sample collection/processing; shipment, scheduling and testing; communicate study design logistics to BAS, monitoring sample shipment logistical issues to prevent associated issues with timely PK, ADA, sTE and RO data analysis driving critical study decisions.
• Establish sample tracking/sample management tools and processes to monitor and verify appropriate samples are shipped to/received by CRO labs and reconcile shipping and sample issues to ensure timely PK, ADA, sTE and RO data analysis driving critical study decisions.
• Author study-specific Bioanalytical Strategy documents for post-FIH through BLA studies.
• Gain alignment between CFTT and CPP for protocol-defined and/or other planned interim data deliveries, including delivery scope.
• Communicate to BAS scientists the type of bioanalytical analyses required (i.e. STAT, cohort-by-cohort, preliminary, etc.).
• Determine the need for bioanalytical reports for all deliveries and communicate appropriately to internal stakeholders.
• Determine and communicate to BAS scientists any stability extension or partial validation needs (new matrices/tissues, co-administration of drugs, new indications, etc.).
• Review/Approve study bioanalytical assay request forms for assays based on study protocols and aligned CFTT/CPP expectations, update as needed.
• Ensure that Biotherapeutic project managers have accurate and credible project plans regarding BAS study needs, including communication of the requested bioanalysis data delivery timelines, the addition of new requested deliveries and updates to bioanalytical scope or requested delivery timelines.
• Track post marketing requirements and commitments related to BAS deliverables to ensure appropriate follow-up is completed.
• Participate in Submission team meetings, determine required support, and track the delivery of BAS’s regulatory submission related deliverables.
• Assure Good Laboratory Practice and Good Clinical Practice compliance with all Bioanalytical Integrator processes.

Qualifications

• Typically, will have a Ph.D. degree (or equivalent) with 0-3 years post-doctoral experience or a minimum of 12 years of experience performing progressively advanced duties beyond a B.S. degree, or at least 3 years of experience performing progressively advanced duties at the Senior Associate Scientist level, or the equivalent training/experience.
• Knowledge of the biologic drug development process from drug discovery to biologics license application.
• Strong expertise in the bioanalytical application of ligand binding assays.
• Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidance for bioanalytical method validation is required.
• Experience with clinical trials is preferred.
• Understanding of pharmacokinetics and biomarkers is preferred.
• The ideal candidate will have a successful track record of problem solving, good organizational habits, excellent communication skills, the ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.
• Attends in-house seminars and participates in scientific meetings as appropriate to support team goals.
• Presents data and recommendations to outside consultants, at in-house research forums and at outside professional meetings.
• Hosts visiting outside scientists; likely to initiate and maintain external collaborations to advance specific projects.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability
Primary Location
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
6889190612