As an expert in analytical development, contributes as part of a small team of scientists and development specialists to the design and implementation of HPLC and LC/MS solutions for the qualitative and quantitative analysis of proteins and glycoproteins in a compliance-based environment. Additional expertise in in vitro/in vivo activity assay development is a plus.
Identifies, strategizes, prioritizes and manages own activities to bring agile resolution to a variety of problems of moderate scope and complexity to support company products in alignment with organizational objectives. Provides mentoring to junior team members and contributes to setting objectives and group priorities.
70% - Development related work and associated protocol/report documentation; presentations and publications; regulatory support; may include Technology Transfer
20% - Organization support and project team participation. Possibility of mentoring direct reports.
10% - Evaluation of new technologies
Education and Experience Requirements:
Ph.D. in Analytical, Chemistry, Biochemistry and Pharmaceutical or related discipline with 0-3 years relevant Postdoctoral or industry experience or an MS in Analytical, Chemistry, Biochemistry and pharmaceutical or related discipline with a minimum of 3 years relevant industry experience or a BS in Analytical, Chemistry, Biochemistry and pharmaceutical or related discipline with a minimum of 8 years relevant industry experience is required
Technical expert in one or more analytical technologies. Knowledge of theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards.
Excellent communication, interpersonal and organizational skills. Proficient with standard computer applications. Proactive at keeping current with literature and latest technologies. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask. Conducts work in compliance with cGMPs, safety and regulatory requirements.
Key Skills, Abilities, and Competencies:
Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development. Keeps current with scientific knowledge in areas of expertise. Provides input to the development of new scientific knowledge.
Applies in-depth knowledge in a number of potential analytical areas including HPLC (such as RP-HPLC, SEC, IEX, UPLC with UV, Fluorescence, and MALLS detection), mass spectrometry, and activity/ligand binding methodologies. Independently guide method development for elucidation and monitoring of primary and secondary structure of proteins and glycoproteins, peptide mapping and quantitation of process- and product-related impurities. Works with management to review progress and strategy in meeting team and project objectives.
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