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:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for our Associate Director, Bioanalysis position located in Spring House, PA.

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

Purpose: The BDDS (Bioanalysis Discovery & Development & Sciences) organization at Johnson & Johnson is seeking an Associate Director to lead the ADA Validation & Sample Testing Group located at Spring House, PA. In this role you will provide scientific and operational leadership for immunogenicity (anti-drug antibodies; ADA) assay validation, transfer, and GLP and clinical study sample testing to support the development and commercialization of a variety of modalities. The ideal candidate will bring deep scientific expertise, meticulous attention to detail, and a passion for advancing biopharmaceutical science — ensuring robust, compliant and scientific strategies, and high‑quality data delivery across development programs.

You will be responsible to:

• Provide strategic and technical leadership for ADA assay validation, qualification, sample testing, transfer, and assay lifecycle activities.
• Supervise nonclinical and clinical sample testing for immunogenicity assessment; ensure timely, accurate, and compliant data generation.
• Design and approve method validation protocols (cut point determination, sensitivity, specificity, precision, robustness, drug tolerance) and review associated reports according to regulatory expectations and departmental SOPs.
• Lead troubleshooting and assay optimization to improve method performance and reliability.
• Ensure all assay and testing activities comply with relevant regulations and guidance (GxP//FDA/EMA immunogenicity guidance) and internal quality standards.
• Manage and mentor a multidisciplinary team of scientists, ; recruit, develop, and retain talent.
• Drive effective communication and cross‑functional collaboration with R/D Clinical, Regulatory, Pharmacokinetics, CMC, Quality Assurance, and Data Management teams.
• Develop and maintain SOPs, technical procedures, and study documentation; participate in QA inspections and regulatory submissions as needed.
• Support ADA assay transfers to CROs, and manage external lab relationships.
• Manage resources, resource planning, timelines, and risk mitigation for validation and sample testing.
• Collaborate with the statistical team to define assay parameters — including cut‑point determination, consistency control acceptance criteria calculation, and variance analysis — evaluate assay performance, and ensure data integrity through robust review processes.

Qualifications/Requirements:

• Bachelor's degree in Immunology, Bioanalytical Chemistry, Biochemistry, Molecular Biology, Pharmacology, or related field required. Advanced degree (MS or PhD) preferred.
• 8–12+ years of progressive experience in bioanalytical/immunogenicity assay development, validation and sample testing, including hands‑on experience with ADA assays required.
• Demonstrated ability in a leadership or people‑management role required.
• Demonstrated expertise with ligand‑binding assays (e.g., ECL, ELISA) required.
• Strong working knowledge of regulatory expectations and guidance for immunogenicity testing (FDA/EMA) required.
• Experience with nonclinical and clinical sample testing under GxP environments and familiarity with documentation and QA processes required.
• Experience with LIMS system, electronic laboratory notebooks, and common bioanalytical data flow required.
• Excellent written and verbal communication skills; able to present complex scientific concepts to cross‑functional and senior leadership audiences required.
• Track record of successful assay transfers to CROs and oversight of external testing partnerships preferred.
• Prior experience supporting regulatory submissions (e.g., regulatory packages for immunogenicity) or participating in inspections preferred.
• Experience with high‑throughput automated platforms and sample management systems preferred.
• Familiarity with PK/ADA integration and interpretation of nonclinical and clinical immunogenicity data 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

 

 

Preferred Skills:

Clinical Pharmacology, Consulting, Continuous Improvement, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Pharmacokinetics, Pharmacology, Pharmacometrics, Product Strategies, Program Management, Report Writing, Researching, Research Proposals, Scientific Research, Standard Operating Procedure (SOP)