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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Principal Scientist, Discovery Bioanalysis to be located in Spring House, PA.

**Purpose:** The Principal Scientist will join the Discovery Bioanalysis group within the Bioanalytical Discovery and Development Sciences (BDDS) organization. The Discovery Bioanalysis group develops fit for purpose methods to provide PK, TK, target engagement, and biomarker quantitative data to meet the fast-paced requirements of therapeutic discovery teams across all therapeutic areas and modalities. They will develop bioanalytical methods using various technical platforms (e.g. hybrid LC/MS-MS, immunoassay, qPCR, etc.) based on project strategy to enable internal decisions to critical questions related to PK/PD, TK, mechanism of action, biodistribution, biotransformation, and matrix stability of therapeutic candidates. They will be focused on establishing platform capabilities for bioanalytical assessments of therapeutic proteins and novel modalities (e.g. antibody-drug conjugates, oligonucleotides, etc.) to support selection and early preclinical safety assessment of lead candidates.

You will be responsible for:

+ All technical aspects of bioanalytical method development activities to characterize in vivo PK, TK, stability, biodistribution, or target engagement for early discovery and non-clinical stage projects.

+ Performing routine study bioanalysis for in vivo PK, PK/PD or nGLP studies for sophisticated modalities.

+ Proactively interrogating existing methodologies to develop process improvements while investigating feasibility of new techniques or analytical platforms for complex modalities.

+ Collaborating within discovery bioanalysis function to identify appropriate bioanalytical methodologies and establish capabilities based on lab capacity and discovery site strategies.

+ Mentoring and cross-training BDDS staff on scientific strategy and technical details of various bioanalytical methodologies.

+ Representing bioanalytical function on discovery and pre-NME portfolio programs and accountable for the interpretation and presentation of complex data sets at cross- functional team meetings.

+ Interacting with key partners (i.e. Translational Pharmacokinetic/ Pharmacodynamics & Investigative Toxicology, Nonclinical Safety, Therapeutics Discovery, Therapeutic Area, Development Bioanalysis groups etc.) to address key project and/or platform questions and contribute to strategic discussions toward lead candidate selection.

Qualifications / Requirements:

Education:

+ A minimum of a Bachelor's degree is required, preferably in Pharmacology, Immunology, Biochemistry or a related field. An advanced degree (Master's, PhD) is preferred.

Experience and Skills:

Required:

+ 6+ years of pharmaceutical research and development experience is required.

+ Solid scientific background and proven track record in bioanalytical method development using various technical platforms to support biopharmaceutical molecules is required.

+ Extensive hands-on assay development experience with different bioanalytical platforms (i.e. LC-MS, hybrid LC-MS, immunoassays/ligand binding, qPCR, etc.) is required.

+ Excellent communication, interpersonal skills, and ability to work across internal or external teams in a matrixed environment is required.

+ Ability to work with human and animal blood or biological specimens is required.

+ Experience with processing and bioanalysis in tissue matrices is required.

+ Ability to work with a high level of autonomy with good documentation and organization skills is required.

Preferred:

+ Experience in pharmaceutical drug discovery research is preferred.

+ Hands on knowledge in quantitative PCR is preferred.

+ Experience in novel modalities such as antibody-drug conjugates, oligonucleotides, and gene therapy platforms is preferred.

+ Regulated bioanalysis and LIMS experience is preferred.

+ Previous people and project leadership responsibilities is preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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