Associate Scientific Director, Molecular Biology and Clinical Pharmacokinetic Assay Development

Employer
J&J Family of Companies
Location
Spring House, Pennsylvania, US
Salary
Competitive
Posted
Jul 27, 2021
Closes
Aug 01, 2021
Ref
2319942609
Field
Development
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Associate Scientific Director, Molecular Biology and Clinical Pharmacokinetic Assay Development, in the Pharmacokinetics and Immunogenicity Assay Development team for the Bioanalytical Sciences group, Biologics Development Sciences within Janssen Biotherapeutics, 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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
Janssen BioTherapeutics (JBIO) supports a wide range of therapeutic areas including Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, Infectious Diseases, and Pulmonary Hypertension. The Bioanalytical Sciences group, Biologics Development Sciences (BDS), develops bioanalytical assays using various analytical platforms to characterize pre-NME lead candidates and post-NME clinical leads in biological samples to enable nonclinical and clinical studies. The Associate Scientific Director, Molecular Biology and Clinical Pharmacokinetics (PK) Assay Development will have the opportunity to contribute to the discovery and development of novel biologic drugs as well as cell and gene therapies by providing scientific and technical expertise on in vivo characterization of PK of protein therapeutics, biodistribution for gene therapies, cellular kinetics of cell therapies, and other novel modalities. The candidate will develop fit-for-purpose bioanalytical methods with primarily qPCR and various platforms to enable internal project teams with answers to key questions related to mechanism of action, Pharmacokinetic/Pharmacodynamic (PK/PD), biodistribution, and assessment of transgene expression.
Principal Responsibilities:
- Represent bioanalytical function on discovery and preNME JBIO portfolio programs through membership on JBIO and cross-functional project teams.
- Interact with biologics discovery teams to address key questions regarding bioanalytical assays and biodistribution through bioanalytical strategy, experimental design, analysis and interpretation of results, and contributing to strategic discussion to help identify optimal molecular designs/constructs suited for lead candidate selection of cell/gene therapies.
- Interact with crossfunctional teams within BDS/JBIO to contribute to clinical bioanalytical strategies for protein therapeutics, cell/gene therapies, and other novel modalities.
- Interact closely with Discovery Translational Research group to enable design in vivo study protocols related to cell/gene therapies, contribute to both nonclinical and clinical bioanalytical strategies for cell/gene therapies, and interpret study results to assess in vivo PK/PD and biodistribution characteristics for cell/gene therapies and other novel modalities.
- Lead all scientific and technical aspects of primarily molecular biologybased method and other bioanalytical platform development activities to support nonclinical and clinical studies and development of assigned projects.
- Be accountable for the assimilation, interpretation and presentation of complex data sets at cross functional team meetings as well as JBIO and BDS scientific discussions.
- Coach and guide staff on scientific concepts and technical details related to bioanalytical strategy and various analytical methodologies.
- Share the technical responsibilities of managing all scientific and technical aspects of externalized bioanalytical method development at Contract Research Organizations (CROs) to support method development using molecular biology platform.
Qualifications
- A minimum of a Master's degree in Pharmacology, Molecular Biology or Virology or a related discipline is required. PhD preferred.
- A minimum of 6 years of experience in pharmaceutical research and development is required.
- Strong scientific background in molecular biology and bioanalysis of analytes in complex biological matrices is required.
- Experience with implementation of molecular biology platforms, such as DNA/RNA extraction techniques, DNA and mRNA detection from biological tissues, is required.
- Knowledge of other bioanalytical platforms, such as LC-MS, immunoassays and automation, is preferred.
- Experience with tissue lysates/extraction for DNA/RNA and protein analysis is highly preferred.
- Knowledge of cell/gene therapies preferred.
- Experience with the direct management of staff is highly preferred.
- Proven record of publications in peerreviewed journals preferred.
- Must have excellent communication and interpersonal skills.
- Must have with good documentation and organization skills.
- Must have the ability to work under limited supervision with a high level of autonomy.
- The ability to work with human and animal blood or biological tissue specimens is required.
- The ability to independently design and execute method development with deep intellectual curiosity is required.
- The ability to collaborate across teams in a matrix environment is required.
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
2105944499W