Janssen Research & Development, LLC., a Johnson and Johnson Company, is hiring a Manager-1 level Scientist (equivalent to Senior Scientist) for the Bioanalytical Sciences (BAS) Department located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Biotech, Inc. delivers on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a legacy of innovative firsts, Janssen Biotech pursues advancing patient care with immunology and oncology solutions. Please visit www.JanssenBiotech.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The department develops laboratory assays to measure 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 candidate will serve as a primary point of contact for all clinical customers – multiple clinical teams (CTs), cross-functional trial teams (CFTTs) and Chemistry, Manufacturing & Controls (CMC) teams – ensuring two-way communication, collating necessary information from BAS and other functions or departments as needed by clinical teams, and ensure the delivery of BAS’s regulatory submission related deliverables. The candidate will work at the Spring House site and flexibility to work from home will be somewhat limited. Additional responsibilities include but are not limited to: Represent all BDS interests on clinical teams. Partner with internal customers colleagues to assure that BAS interests are captured and represented. Communicate updates on immunoassay development, validation, and technical issues to customers but when complex scientific questions arise, invite BDS Functional Area Leads ad hoc to clinical teams to discuss scientific issues Communicate to BAS scientists the finalized dosing concept for method design developed by the clinical team, need for cohort by cohort or preliminary analyses, alert laboratory functions for stability extension/partial validation needs (new matrices/tissues, co-administration of drugs, new indications, etc) Manage CT 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; communication of study design logistics to BDS, monitoring and resolution of sample shipment logistical issues proactively to prevent associated issues with timely PK and RO data analysis driving critical study decisions Ensure that project managers have accurate project plans regarding study needs and provide accurate estimates of study timings and deliverables. Monitor these plans to ensure credibility. Complete study bioanalytical assay request forms for assays based on study protocols, update as needed In collaboration with laboratory scientists and clinical pharmacology colleagues provide appropriate input into clinical protocols and regulatory submissions pertaining to sampling and bioanalytical testing for PK, ADA, NAb, RO and sTE Track post marketing requirements (PMRs) and commitments (PMCs) related to BAS deliverables
Ph.D. or Pharm.D. with a minimum of 3 years’ experience involving bioanalysis for clinical trials, pharmacokinetics, biomarkers, or clinical team representation OR a M.S. with a minimum of 8 years’ experience involving bioanalysis for clinical trials, pharmacokinetics, biomarkers, or clinical team representation is required Experience or demonstrated understanding of the Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) is preferred Experience with clinical trials is required Familiarity with regulatory requirements is preferred Understanding of pharmacokinetics and biomarkers is preferred
Primary LocationNorth America-United States-Pennsylvania-Spring HouseOrganizationJanssen Research & Development, LLC. (6084)TravelYes, 10 % of the TimeJob FunctionR&D
Internal ID: 2644171016
Location/Region: Spring House, PA (US)