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The Senior Research Associate PDP & Mfg. plays a critical role as a cGMP scientist and operator, supporting the development and manufacturing of investigational drug products for plasma fractionation immunotherapies. This position is responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and regulatory guidelines throughout all phases of product development, from research to commercial-scale production.
Job Responsibility:
Assist in writing and updating related SOPs, records, protocols, reports
Maintain accurate records of activities
Perform bench-scale protein purification
Lead purification needs for reagent production
Work towards optimizing purification methods and protocols for increased yield and purity
Create purification methods in chromatography software programs
Perform statistical analysis as needed
Collaborate with the Supervisor to execute projects to meet timelines
Support the training of associates in purification activities
Purify and Filling product as needed based on Clinical needs
Assist other research associates in purification activities
Assist with Shipping, Receiving, and Ordering related to PDP & Manufacturing
Assist with cleaning activities as needed in the Cleanrooms and Bench area
Perform calibrations and maintenance events on equipment related to PDP and Manufacturing
Other duties as assigned
Requirements:
Bachelor’s degree and minimum 3 years of relevant experience or a combination of experience and Master’s or Doctorate degree in a relevant field
Certification in Quality by Design is a plus
Demonstrated proficiency in Microsoft Office applications Word, Excel, PowerPoint, Outlook
Familiarity with chromatography software, preferably Cytiva UNICORN
Basic computer programming knowledge to support use of UNICORN software
Mathematical skills to consist of addition, subtraction, multiplication, division and ability to perform basic statistical analysis, including mean, median, range, mode, standard deviation calculations and related analysis
Ability to calculate dilutions and molarity
Strong time management and organizational skills
Demonstrated ability to effectively work independently with minimal supervision
Excellent verbal and written communications skills and a collaborative approach work
Physical ability to walk, stand, sit and regularly lift and/or move up to 10 pounds
Able to wear aseptic gowning for extended periods of time