Scientist, Analytical and Formulation Development

Overview: Development of analytical methods and formulations for protein therapeutics

Responsibilities

·      Provide scientific leadership in developing analytical methods and formulation of protein therapeutics in collaboration with client and internal stake holders

·      Ability to manage multiple activities within one project

·      Be a role model technically and behaviorally, showing leadership capabilities

·      Able to train junior staff, providing scientific guidance / assistance, ensuring effective delivery on project goals, and where appropriate, managing their performance 

·      Develop assays for release and stability testing and characterization of protein therapeutics 

·      Support qualification of test methods, authoring analytical procedures, writing assay qualification protocols and reports for QC testing with technical and Quality oversight 

·      Use and maintain equipment per operational SOPs; revise procedures as needed

·      Draft and review buffer /solution / sample preparation sheets as relevant, and prepare them with accuracy in calculations and measurements

·      Execute test methods independently and accurately document procedures in compliance with cGMPs and in a timely manner. 

·      Ensure applicable GMP training is current before performing QC assays

·      May serve as a verifier during GMP testing, ensuring compliance 

·      Assist with investigations for deviations and corrective actions of work done

·      Provide raw data and powerpoint summaries that are accurate, complete with appropriate details, presentable to client, and requiring minimum revisions

·      Able to draft reports as needed with some interpretations that may require revisions

·      Run procedures with minimal rework

·      Be flexible and available to address issues outside of working hours 

·      Place documents in appropriate client folder and binders, organized in a traceable manner

·      Required to make accurate basic algebraic calculations, able to plot curves, and interpret results accordingly

·      Maintain cleanliness of the offices and work areas

·      Enforce laboratory safety measures.  Use and stock personal protective equipment in work areas. Comply with established waste disposal procedures

·      Understand equipment use requirements, obtain quotes for maintenance, calibration, and qualification

·      Able to troubleshoot and provide assistance to others for troubleshooting methods, equipment malfunction, facility issues and other laboratory needs

·      Promptly alert management of technical, equipment, facility, project or GMP issues

·      Required to be compliant with GMP regulations, where applicable

Credentials and Experience

·      PhD in a science field or Masters in engineering with 0-3 years of laboratory or Masters in science with 3-7 years biologics experience or Bachelors with 7-10 years of biologics experience

·      Experience with cGMPs or work in other regulated industries

Competencies

·      Drive and flexibility to meet objectives efficiently and handle shifting priorities in a fast-paced environment

·      Detail oriented with high work accuracy

·      Team player, contributing to a positive work environment

·      Willing to learn and train on new procedures

·      Good written and oral communication skills