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We are searching for the best talent for our Sr. Scientist, Biologics Analytical Development position to be located in Malvern, PA.

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.

• Developing, validating, and transferring biochemical methods (e.g., capillary electrophoresis and HPLC) for the characterization and quality control of biopharmaceutical products
• Serving as the analytical subject matter expert during method development, investigations, and regulatory inspections
• Identifying, evaluating, and implementing innovative technologies and approaches to address emerging analytical challenges for new modalities
• Leading one or more analytical projects, collaborating with analytical integrator and cross-functional partners (e.g., process development scientists, QC scientists) to support programs from early clinical development through commercialization
• Providing analytical expertise to support programs across early- and late-stage clinical development and commercial manufacturing
• Leading continuous improvement initiatives to enhance analytical methods, processes, and laboratory practices
• Analyzing complex data sets and communicating findings clearly and concisely to technical and non-technical stakeholders
• Authoring, reviewing, and approving analytical methods, validation and transfer protocols, technical reports, and standard operating procedures, and presenting data to peers and functional leadership
• Authoring and reviewing sections of regulatory submissions (e.g., INDs, IMPDs, BLAs) and responding to health authority inquiries
• Contributing to laboratory operations improvements to enhance efficiency and ensure compliance with Good Manufacturing Practices (GMP)

• Ph. D. in Biochemistry or a related scientific field with 0-4 years of Pharma/biotech industry or post-doctoral experience OR a Master's degree with a minimum 5 years of Pharma/biotech industry experience OR Bachelor's degree with a minimum of 12 years of relevant work experience.

Required:

• Strong foundation in biochemistry is required.
• Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives is required.
• Proven scientific expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography is required.
• Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is required.
• Excellent organization, communication, presentation skills and scientific/technical writing skills is required.
• Excellent leadership, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams is required.
• In-depth large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques is preferred.
• Experience with commercialization of therapeutic proteins is preferred.
• Must be meticulous, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data is preferred.
• Ability to make timely decisions and operate efficiently in times of ambiguity is preferred.

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