Associate Director, Bioanalysis

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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 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 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 highquality 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 crossfunctional 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 cutpoint determination consistency control acceptance criteria calculation and variance analysis evaluate assay performance and ensure data integrity through robust review processes.

Qualifications/Requirements:

• Bachelors degree in Immunology Bioanalytical Chemistry Biochemistry Molecular Biology Pharmacology or related field required. Advanced degree (MS or PhD) preferred.
• 812 years of progressive experience in bioanalytical/immunogenicity assay development validation and sample testing including handson experience with ADA assays required.
• Demonstrated ability in a leadership or peoplemanagement role required.
• Demonstrated expertise with ligandbinding 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 crossfunctional 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 highthroughput 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 internal employees contact AskGS to be directed to your accommodation resource.

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