Johnson & Johnson Careers
Senior Scientist, Bioanalytical Integrator
Requisition ID: 3504190829
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior 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 Bioanalytical Sciences (BAS) group within Janssen BioTherapeutics, develops laboratory assays to measure pharmacokinetic (PK), anti-drug antibody (ADA) and neutralizing antibody (NAb) responses in biological matrices, and the in vivo interaction of biopharmaceutical drugs with their protein targets, both on cell surfaces (receptor occupancy, RO) and in soluble forms (soluble target engagement, sTE). These assays are used to perform bioanalysis on non-clinical and clinical studies that enable drug candidate selection, human dosage recommendation, and support PK, immunogenicity, safety and efficacy analyses in clinical trials.
The Bioanalytical Integrator will serve as a primary point of contact for interactions with internal BioTherapeutics functional teams (including JBIO Project Management, Trial Support and Laboratory Support) and BAS 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 BAS’s regulatory submission-related projects.
- Represent BAS interests to clinical teams (First-in-Human through BLA). Partner with internal colleagues to assure that BAS interests are captured and represented in 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.
- 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 finalized dosing concept for method design developed by the clinical team.
- 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 Biotherapuetics 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.
- Typically, will a have Ph.D. degree in biotechnology, immunology, biochemistry, molecular biology or a related field with 5-8 years of business experience or 3-5 years of business experience performing progressively advanced duties at the Scientist level, or the equivalent training/experience.
- Strong knowledge of the biologic drug development process from drug discovery to biologics license application.
- 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 preferred
- Experience with clinical trials is required.
- 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.
- Endeavors to establish a scientific reputation through scientific accomplishments directed toward the discovery and development of therapeutic agents for the company, including publishing work in journals, participating in patent preparation, oral presentations within and outside J&J across different therapeutic areas/functions/geographies, and participating in professional societies.
- Identifies consultants and special scientific lecturers and arranges for them to visit; maintains multiple external relationships.
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
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Janssen Research & Development, LLC (6084)