Experienced Scientist, Biotherapeutics R&D

Johnson & Johnson Innovative Medicine; Malvern (Chester County); Hybrid; USD 95,000 - 135,000; Full time

Job summary

Johnson & Johnson Innovative Medicine R&D in Malvern, PA, is recruiting an Experienced Scientist, Biotherapeutics R&D, for a hybrid role. You will lead development of bioassays and binding assays, qualify and transfer methods, and support regulatory filings for clinical and commercial products.

The role requires a bachelor’s or master’s in biology/biochemistry-related fields and 4+ years of industry experience; GMP experience and flow cytometry are preferred.

Qualifications

• Bachelor’s degree in biology, pharmacology, immunology or biochemistry with 4+ years of industry experience, or Master’s with 2+ years or relevant academic experience.
• Experience in development of bioassays, binding assays and/or immunochemical techniques.
• Experience with cell culture and aseptic technique.
• Strong written and verbal communication skills; ability to influence others.
• Experience working in or with GMP environments preferred; familiarity with flow cytometry is a plus.

Responsibilities

• Author protocols and reports; coordinate testing to support analytical development, manufacturing process development, and investigations.
• Maintain detailed records ensuring data integrity and GMP compliance.
• Design, troubleshoot, and execute experiments; analyze data and report results; collaborate to resolve assay problems.
• Contribute to regulatory submissions by writing analytical sections for INDs and BLAs.
• Provide technical support to development and QC labs and support QA, Regulatory Affairs and Process Development across product lifecycle.

Skills

Analytical Reasoning

Biochemistry

Molecular Diagnostics

Pharmacology

Immunology

Written Communication

Education

Bachelor’s degree in Biology

Bachelor’s degree in Pharmacology

Bachelor’s degree in Immunology

Bachelor’s degree in Biochemistry

Master’s degree (relevant field)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

Johnson & 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 bachelor’s degree in biology, Pharmacology. Immunology, Biochemistry, or other relevant scientific fields, with at least 4 years of industry experience, or a master’s 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:

  • 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 https://www.jnj.com/contact-us/careers, 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