Experienced Scientist, Biotherapeutics R&D

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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 & Johnson Innovative Medicine R&D is recruiting for an Experienced Scientist Biotherapeutics R&D. This position is a hybrid role and will be located in Malvern PA.

Purpose:

The Experienced Scientist Bioassay Methods Development will be responsible for the development of cell-based bioassays and binding assays to be used as QC potency assays and in support of structure-function and biological characterization studies to better understand the mechanism of action for new molecular entities in clinical development and for commercial products. The individual will be accountable for method development qualification validation and transfer activities as well as the evaluation of new technologies.

You will be responsible for:

• Authoring protocols and reports. Performing and coordinating testing to support analytical development manufacturing process development process validations and manufacturing investigations across functional groups
• Accurately recording data in a timely manner including maintenance of detailed records in compliance with applicable GMP safety and environmental requirements. The successful candidate will ensure data integrity and protocol compliance
• Designing troubleshooting and executing experiments independently. Analyzing data interpreting results and reporting data in laboratory notebooks. Collaborate with partners to troubleshoot assay problems as they occur. Maintain awareness of the current literature relevant to methods
• Writing analytical sections of regulatory submissions is encouraged. The candidate will support regulatory filings including INDs and BLAs
• Providing technical support with development and QC laboratories is expected and the successful candidate will also support Quality Assurance Regulatory Affairs and Process Development groups for all phases of product development as well as ongoing support of analytical methods for marketed products

Qualifications/Requirements:

Required:

• A minimum of a bachelors degree in biology Pharmacology. Immunology Biochemistry or other relevant scientific fields with at least 4 years of industry experience or a masters degree with at least 2 years of industry experience or relevant academic experience.
• Experience in development of bioassays binding assays and/or immunochemical techniques is required.
• Experience with cell culture and aseptic technique is required.
• The ability to communicate ideas and influence others is essential.
• Strong technical writing and verbal communication skills are required.
• Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment.

Preferred:

• Prior experience in a GMP environment is preferred.
• Experience with flow cytometry is preferred.
• Prior experience in the biotechnology or pharmaceutical industry (therapeutic proteins/antibodies cell and gene therapies and/or vaccines) is preferred.
• Experience with laboratory automation is preferred.
• Preferred skills would include method robustness DoE method design and familiarity with assay validation parameters.

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.

Required Skills:

Preferred Skills:

Analytical Reasoning Biochemistry Chemistry Manufacturing and Control (CMC) Coaching Collaboration Conducting Experiments Data Quality Drug Discovery Development Molecular Diagnostics Patent Applications Pharmacogenetics Report Writing Research Documents Scientific Research Technologically Savvy Written Expression

Required Experience:

Senior IC