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Scientist II in Biotech
The Sr.? Consultant is responsible for the independent management of assigned projects.? This includes the evaluation, development and validation of methods required for raw materials and finished products.? Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project.? Conducts research to develop or improve analytical techniques, methodology, procedures and investigates application of instruments in analysis.? Organizes and interprets all data obtained using a wide variety of instrumental technologies.? Evaluates new technologies for application to the current and future business needs.? Implements QC specifications to ensure process consistency, quality and optimal performance.? Ascertains relationships between molecular structure and physical properties to aid in the analysis of compounds.?
The Sr.? Consultant is responsible for understanding the Change Control system and the requirements for submitting validation reports and protocols so as to fully implement method requirements and specifications.? The Sr.? Consultant must work cross-functionally to ensure the success of assigned projects.? The Sr.? Consultant is considered a subject matter expert in several testing disciplines and is responsible for training new team members on all aspects of testing and project management.? Establishment and Implementation of Internal Release Limits.? Assessment and Establishment of Product Expiry Dating.? Demonstrates technical and theoretical understanding of all raw material and finished product methodology in support of projects.? Seeks out opportunities to evaluate technologies applicable to Quality Control testing.? Trains new team members.? Shows a thorough comprehension of various project systems and process flows including Alternate Source and Analytical technical transfer.? Proficient in routine analytical testing for both raw material and finished products in support of projects.? Pursues subject matter expert status for a specific technology or testing discipline.? Develops analytical methods for full range of testing in both Raw Materials and Finished Products.? Selects appropriate methodologies, technology and techniques for those methods to be validated.? Thorough understanding of Change Control process.? Writes and reviews validation protocols and reports.? Adept at instrumentation trouble shooting.? Works with customers in QC Supply Chain, Quality Assurance, Regulatory Affairs and Technical Services to ensure the customer needs are understood and met.? Ensures all company policies and procedures are adhered to.? Performs other duties as assigned.? Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.?
Minimum requirements BS, MS, PhD, JD, MD, DVM.? English.? Minimum 15yrs.? Pharmaceutical method development/?validation experience with PhD required.? BS or MS with significant method development/?validation experience in a pharmaceutical environment will be considered only in exceptional cases.?
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