Sr. Scientist, Biologics Analytical Development
6084-Janssen Research & Development, LLC Legal Entity
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Job summary
Johnson & Johnson in Malvern, PA seeks a Sr. Scientist, Biologics Analytical Development to lead development, validation and transfer of separation assays for protein biotherapeutics, including monoclonal antibodies and antibody drug conjugates, to support clinical and commercial programs.
You will oversee method development, troubleshooting, and regulatory interactions, collaborate across cross-functional teams, and drive continuous improvement while ensuring GMP compliance and data integrity.
Qualifications
- Education requirements vary: PhD w/ 2+ years pharma/biotech experience OR MS w/ 5+ years OR BA/BS w/ 12+ years pharma/biotech experience.
- Strong analytical and problem-solving skills; ability to develop creative solutions and achieve objectives.
- Extensive hands-on experience with protein isolation and separation techniques (electrophoresis, chromatography).
- Excellent scientific and technical writing, communication, and leadership abilities.
Responsibilities
- Develop, validate, and transfer biochemical methods (capillary electrophoresis, HPLC) for QC of biopharmaceuticals.
- Serve as analytical SME for method development, investigations, and regulatory inspections.
- Identify and implement innovative technologies to address analytical challenges.
- Lead analytical projects and collaborate across cross-functional teams to support programs.
- Provide analytical expertise across early to late-stage development and manufacturing.
- Drive continuous improvement of methods, processes, and lab practices.
- Analyze data and present findings clearly to technical and nontechnical stakeholders.
- Author/review/approve methods, validation/transfer protocols, reports, and SOPs; present data to leadership.
- Contribute to regulatory submissions (INDs, IMPDs, BLAs) and health authority responses.
Skills
Education
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.
Discovery & Pre-Clinical/Clinical Development
Biotherapeutics R&D
Scientific/Technology
All Job Posting Locations: Malvern, Pennsylvania, United States of America
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 Sr. Scientist, Biologics Analytical Development.
Therapeutics, Development, and Supply (TDS), Proteins Analytical Development (AD) group is seeking a Sr. Scientist to support our dynamic Analytical Development (AD) Separation Sciences team. The experienced and motivated Senior Scientist will be responsible for development, validation, and transfer of separation assays for protein biotherapeutics including but not limited to monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates to be used in support of clinical and commercial development. You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.
- Develop, validate, and transfer biochemical methods, including capillary electrophoresis and HPLC, for the characterization and quality control of biopharmaceutical products
- Serve as the analytical subject matter expert for method development, investigations, and regulatory inspections
- Identify, evaluate, and implement innovative technologies and approaches to address emerging analytical challenges associated with new modalities
- Lead one or more analytical projects and collaborate with analytical integrators and cross-functional partners, including process development and QC scientists, to support programs from early clinical development through commercialization
- Provide analytical expertise to support programs across early- and late-stage clinical development and commercial manufacturing
- Lead continuous improvement initiatives that enhance analytical methods, processes, and laboratory practices
- Analyze complex data sets and communicate findings clearly and concisely to technical and nontechnical stakeholders
- Author, review, and approve analytical methods, validation and transfer protocols, technical reports, and standard operating procedures; present data to peers and functional leadership
- Author and review sections of regulatory submissions, including INDs, IMPDs, and BLAs, and respond to health authority inquiries
- Contribute to laboratory operational improvements that increase efficiency and maintain compliance with Good Manufacturing Practices (GMP)
- Education Required: Ph. D. in Biochemistry or a related scientific field with 2+ years of Pharma/biotech industry or post-doctoral experience OR a Master's degree with 5+ years of Pharma/biotech industry experience OR Bachelor's degree with 12+ years Pharma/biotech industry experience.
- Experience and Skills:
- Required: A strong foundation in biochemistry is required. Strong analytical and problem-solving skills, with the ability to develop creative solutions and achieve project objectives, are required. Demonstrated scientific expertise and extensive hands-on experience with protein isolation and separation techniques, including electrophoresis and chromatography, are required. Excellent organizational, communication, presentation, and scientific and technical writing skills are required. Excellent leadership, interpersonal, and negotiation skills, with the ability to work effectively in a dynamic environment and collaborate across functions, are required.
- Preferred: Knowledge of method robustness, design of experiments (DoE), method design, and assay validation parameters is preferred. In-depth experience in large-molecule analytical development, with an emphasis on separation methods such as HPLC and capillary electrophoresis, is preferred. Experience applying AI in analytical development, knowledge of advanced analytical technologies, and familiarity with relevant regulatory guidance, including ICH Q2(R2) and ICH Q14, are preferred. Experience supporting the commercialization of therapeutic proteins is preferred. Meticulous attention to detail, strong organizational skills, and the ability to manage multiple priorities, meet tight timelines, and deliver high-quality data are preferred. The ability to make timely decisions and operate effectively amid ambiguity is preferred. #LI-Hybrid
- 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
- 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
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. Ifyou 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.
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 https://www.jnj.com/.
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