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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Biotherapeutics R&D
Job Category:
Scientific/Technology
All Job Posting Locations:
Malvern, 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 Senior Automation Scientist, Bioassay Development to be located in Malvern, PA.
Purpose: The Senior Automation Scientist, Bioassay Methods Development, will be responsible for developing, implementing, and optimizing laboratory automation solutions for biological, biochemical, cell-based, and binding assay workflows that support analytical development, QC potency assays, structure-function studies, and biological characterization for clinical and commercial products. The individual will partner with assay development scientists and cross-functional stakeholders to transfer manual methods onto automated liquid-handling platforms, improve throughput, reproducibility, and data quality, and support the evaluation, qualification, and lifecycle management of new automation technologies.
You will be responsible for:
- Designing, developing, optimizing, and implementing automated laboratory workflows for biological, biochemical, cell-based, binding, and immunochemical assays used in analytical development, QC testing, and product characterization.
- Transferring manual assay procedures onto automated liquid-handling platforms and integrated workcells, including development of scripts, liquid classes, deck layouts, method work instructions, and supporting documentation.
- Collaborating with Bioassay Methods Development, Analytical Development, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, Digital and Automation teams, and external vendors to define automation requirements, troubleshoot workflows, and deliver robust automated solutions.
- Evaluating, selecting, qualifying, and supporting implementation of laboratory automation technologies, including liquid handlers, robotic platforms, workflow-management software, data-handling tools, and associated instrumentation.
- Completing feasibility studies, optimization experiments, and method performance assessments to demonstrate that automated workflows meet scientific, compliance, data integrity, and business needs.
- Authoring and reviewing protocols, technical reports, work instructions, equipment procedures, training materials, and documentation supporting automation development, qualification, validation, transfer, and lifecycle management activities.
- Accurately recording, analyzing, interpreting, and communicating experimental and automation performance data in compliance with applicable GMP, safety, data integrity, and environmental requirements.
- Maintaining awareness of emerging laboratory automation technologies and seeing opportunities to increase efficiency, standardization, reproducibility, and scientific impact across the Bioassay Methods Development portfolio.
Qualifications/Requirements
Education:
- A minimum of a Bachelor's degree in Bioengineering, Automation Engineering, Biomedical Engineering, Biology, Biochemistry, Chemistry, Pharmacology, Immunology, or another relevant scientific or engineering field, with at least 7 years of relevant industry experience; a Master's degree with at least 5 years of relevant industry experience; or a PhD with 2 years of relevant experience is required.
Experience and Skills:
Required:
- Hands-on experience developing, optimizing, implementing, or supporting laboratory automation workflows in a pharmaceutical, biotechnology, analytical development, or regulated laboratory environment.
- Experience with automated liquid-handling platforms, such as Hamilton and/or Tecan systems, including script development, method optimization, troubleshooting, and routine operational support.
- Experience automating biological, biochemical, cell-based, binding, immunochemical, molecular biology, or related analytical assay workflows.
- Working knowledge of assay development, method optimization, qualification, validation, transfer, and lifecycle management principles.
- Demonstrated ability to collaborate effectively with assay scientists, automation engineers, data/digital partners, Quality, Regulatory, Process Development, vendors, and other cross-functional partners.
- Experience with and understanding of Quality Systems, in particular implementing change in a multi-site organization.
- Ability to engage with Quality Assurance (QA) to develop automation solutions in a regulated environment.
- Ability to communicate ideas, influence others, and translate scientific requirements into practical automation solutions is essential.
- Strong technical writing, documentation, data analysis, troubleshooting, and verbal communication skills.
- Excellent interpersonal skills with the ability to operate effectively in a dynamic, cross-functional work environment.
Preferred:
- Experience with Hamilton Star, Tecan Fluent/EVO, Biosero, Cellario, or comparable liquid-handling and workflow automation software.
- Experience with integrated automation workcells, scheduling software, robotic systems, automated sample preparation, automated reporting, or data integration tools.
- Experience automating cell-based bioassays, flow cytometry workflows, molecular biology workflows, qPCR/ddPCR assays, ELISA, HTRF/TR-FRET, or other bioanalytical methods.
- Prior experience as a test analyst in the biotechnology or pharmaceutical industry, including therapeutic proteins, antibodies, bispecifics, cell and gene therapies, vaccines, or other advanced therapeutics.
- Prior experience in a GMP environment and familiarity with equipment qualification, computerized system considerations, data integrity expectations, and compliant documentation practices.
- Preferred skills include automation troubleshooting, liquid-class optimization, workflow mapping, and cross-site technology transfer.
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.
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
#LI-Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy
