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:You will be responsible for:- 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)
Qualifications/Requirements: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
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
