Janssen research & development, l.l.c., a division of johnson & johnson`s family of companies is recruiting for a clinical bioanalysis scientist in spring house, pa or remote for the right candidate.
At the janssen pharmaceutical companies of johnson & johnson, we are working to create a world without diseaseTransforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires usWe bring together the best minds and pursue the most promising scienceWe are janssenWe collaborate with the world for the health of everyone in itLearn more at www.janssen.com and follow us @janssenglobalJanssen research & development, llc is part of the janssen pharmaceutical companies.
The clinical bioanalysis scientist serves as the bioanalytical sciences scientist responsible for execution of study bioanalysis for assigned clinical programsServes as an individual contributor who is responsible for: development of bioanalytical strategies & bioanalytical plans for all phases of clinical programs, oversight of study bioanalytical timelines and data review, and review of critical bioanalytical data and assay trendingThe clinical bioanalysis scientist serves as a primary contact for interactions with internal functional teams (including project management, trial support and laboratory support) and clinical stakeholders [including clinical pharmacology and pharmacometrics, clinical teams, cross-functional trial teams, compound development teams and chemistry, manufacturing & controls to ensure two-way communication of information necessary for delivering bioanalytical sciences’ regulatory submission-related projects.
The clinical bioanalysis scientist uses experience in bioanalytical sciences to guide the formation of bioanalytical strategies and resolutions of project related bioanalytical issuesTechnical leadership and project management requirements are below.
Responsibilities to include the following:
Accountable for documenting bioanalytical strategies (e.gSelection of analytes, desired assay attributes, applicable matrices, and validation strategies etc.) for all phases of clinical programs
Accountable for documenting and communicating bioanalytical plans to external stakeholders
Guide continuous validation strategies for product life cycle (e.g., for new indications, assay placement, combination studies, etc.)
Review and contribute to study protocol pharmacokinetic (pk), target engagement (ste), and immunogenicity (ada/nab) sampling time points.
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 teams for bioanalytical related questions, concerns, issues, timelines, etc.
Establish sample tracking/sample management tools and processes to monitor and verify appropriate samples are shipped to/received by contract research organization labs and reconcile shipping and sample issues to ensure timely pk, ada, ste and receptor occupancy (ro) data analysis driving critical study decisions
Review all supply agreements, study protocols and regulatory submissions pertaining to sampling and bioanalytical test, central lab sows, data flow diagrams, and laboratory manuals
Seek to contribute to improving business/work processes to identify and enable scientists to cultivate new scientific insights
Communicate overall strategy of the projects to internal or external stakeholders
Core responsibilities:
Assure good laboratory practice and good clinical practice compliance with all clinical bioanalytical scientist processes.
Participate in submission team meetings, determine required support, and track the delivery of regulatory submission related deliverables.
Author study-specific bioanalytical strategy documents for post first-in-human through biologics license application (bla) studies.
Determine and communicate to bioanalytical sciences any stability extension or partial validation needs (new matrices/tissues, co-administration of drugs, new indications, etc.).
Collaborate with team members on study bioanalytical assay request forms for assays based on study protocols and aligned clinical team expectations, update as needed.
Attend in-house seminars and attend scientific meetings as appropriate to support team goals.
This is not an exhaustive, comprehensive listing of job functionsMay perform other duties as assigned.
Qualifications
Education: ph.dDegree (or equivalent) with 0-3 years post-doctoral experience or a minimum of 8 years of experience performing progressively advanced duties beyond a b.sDegree, or at least 3 years of experience performing progressively advanced duties at the senior associate scientist level, or the equivalent training/experience
Experience/special skills: knowledge of the biologic drug development process from drug discovery to biologics license applicationStrong expertise in the bioanalytical application of ligand binding assays.
Johnson & johnson is an affirmative action and equal opportunity employerAll 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
Other locations
North america-united states
Organization
Janssen research & development, llc (6084)
Job function
R&d
Requisition id
2105967747w
