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 MedicineOur 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 two
Senior Scientists, Proteins, Analytical Development.
Purpose: The Therapeutics, Development, and Supply (TDS), Proteins Analytical Development (AD) group is seeking two Senior Scientists to support our dynamic Analytical Development Separation Sciences team. The experienced and motivated Senior Scientists 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.
You will be responsible for:- Develop, validate, and transfer biochemical methods such as capillary electrophoresis (CE) and HPLC methods for characterization and quality control of biopharmaceutical products
- Serve as the analytical technical expert during method development, investigations, and regulatory inspections
- Seek and implement innovative technology and approaches for analytical method development to meet increasing analytical challenges for new modalities
- Lead one or more analytical projects and partner with process development scientists, analytical integrator, QC scientists to support programs ranging from early phase through late phase clinical development and commercial manufacturing
- Provide deep analytical expertise for programs ranging from early phase through late phase clinical development and commercial manufacturing
- Lead continuous improvement initiatives for methods, processes, and scientific procedures.
- Analyze and communicate complex data clearly and succinctly
- Write, review, and approve methods, validation/transfer protocols, technical reports, SOPs and present data to peers and functional management
- Author/review relevant sections of regulatory filings including but not limited to INDs, IMPDs and BLAs and address inquiries from the health authorities
- Contribute to improvement in laboratory operations to increase efficiency and GMP compliance
Qualifications / Requirements:Education: Ph.D. with 2+ years, a master's degree with 5+ years, or a bachelor's degree with 12+ years of relevant biochemical work experience. Degrees in biochemistry or related scientific fields preferred.
Experience and Skills:Required:- Strong Biochemistry background
- Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives
- Proven scientific expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography
- Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
- Excellent organization, communication, presentation skills and scientific/technical writing skills
- Excellent leadership, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams
Preferred:- In-depth large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques
- Experience with commercialization of therapeutic proteins
- Must be meticulous, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data
- Ability to make timely decisions and operate efficiently in times of ambiguity
#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
