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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:
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 and Johnson is currently seeking a Principal Scientist, Bioassay Methods Development, located in Malvern, PA.
The Principal 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 mechanism of action for new molecular entities in clinical development and for commercial products. This role will also build and maintain strong relationships with Discovery partners to gain earlier insight into products entering development, increasing speed and facilitating readiness for cell-based assay development. The individual will be accountable for method development, qualification, validation, and transfer activities as well as the evaluation of new technologies.
Key Responsibilities:
- 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.
- Establishing and strengthening partnerships with Discovery teams to understand emerging product attributes, anticipated assay needs, and development timelines, enabling earlier planning and readiness for cell-based assay development.
- 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.
- Authoring and reviewing analytical sections of regulatory submissions (INDs, BLAs, MAAs).
- 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.
- Lead matrix teams, with potential responsibility for supervising 2–3 direct reports.
Qualifications
Education:
- A minimum of a Bachelor's degree in Biology, Pharmacology. Immunology, Biochemistry, or other relevant scientific fields, with at least 9 years of industry experience, a Master's degree with at least 7 years of industry experience, or a PhD with 4 years of relevant experience is required.
Experience and Skills:
Required:
- Experience in development of bioassays, binding assays, and/or immunochemical techniques.
- Experience with cell culture and aseptic technique.
- Prior experience in the biotechnology or pharmaceutical industry (therapeutic proteins/antibodies, cell and gene therapies, and/or vaccines).
- Previous leadership experience (matrix leadership, coaching, mentoring, leading projects) is required.
- The ability to communicate ideas and influence others is essential.
- Strong technical writing and verbal communication skills.
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment.
Preferred:
- Experience with direct people management, coaching, and employee career development.
- Experience with automated liquid handlers (e.g. Tecan or Hamilton).
- Experience with flow cytometry.
- Experience with Biacore and/or other surface plasmon resonance technology.
- Prior experience in a GMP environment.
- 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.
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.
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations,
Clinical Trial Designs, Coaching, Critical Thinking, Drug
Discovery Development, Emerging Technologies,
Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research