Scientist, Analytical Development

 

Our Immunotherapy client located in Lexington, MA is growing and looking to add a Scientist, Analytical Development to their team!  In this hands-on, laboratory-based role, will be responsible for the development, qualification, and routine performance of robust analytical methods. Working closely with Process Development and Manufacturing teams, the candidate will coordinate and execute testing activities and author technical protocols and reports, as applicable. 

Responsibilities:

  • Execute analytical testing for non-GMP and  GMP release and stability testing for assays such as Appearance, pH, Osmolality, HPLC methods (Ion Exchange, Size Exclusion, Affinity Protein A Chromatography (APAC)),  icIEF, CE-SDS, ELISA plate-based methods (Binding, Residual Host Cell Protein, Residual Protein A), and Residual Host Cell DNA (qPCR)
  • Adhere to Good Manufacturing Practices by completing and maintaining cGMP documentation (electronic and Hard Copy) for work performed
  • Support of generation of specifications and CoAs for product release, lot disposition by entering results for release and stability samples, reviewing data for compliance, and performing trend analysis
  • Develop robust and reproducible analytical methodologies for evaluating product quality attributes
  • Support method transfer and phase-appropriate qualification/validation of analytical methods for internal and external contract testing laboratories
  • Write/revise and execute protocols, reports, Test methods, and SOPs as needed.
  • Support OOS, deviations, change controls, and CAPA investigations, including the execution of troubleshooting activities, as necessary
  • Support raw materials management and environmental monitoring programs
  • Support establishment of method performance monitoring 
  • Assist in coordinating sample management activities such as shipment, receiving, and inventory management
  • Support Regulatory filings through data entry and data verification.
  • Establish and maintain a safe laboratory working environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected
  • Support Drug Product Development Studies as needed. This can include, but is not limited to:
    • Protocol/report writing and reviewing for formulation DOE and in-use compatibility studies, in addition to execution of sample testing
    • Coordinating drug product fills with CDMOs
    • Serve as general person-of-contact for particular products
    • Foster interdepartmental communication/collaboration on studies for both AS&QT and Downstream Process Development

Requirements:

  • PhD preferred with 1-2+ years, Master’s degree with 8+ year or BS with 5+ years experience in analytical development and quality control in pharma/biotech
  • Experience with analytical techniques for protein analysis (e.g., HPLC, CE-SDS, IcIEF, ELISA, qPCR) is required; working knowledge of laboratory software (e.g., Empower, Compass, SoftMax, AccuSEQ, SoloVPE) is highly preferred
  • Knowledge of analytical testing concepts and current cGMPs, including laboratory controls and good documentation practices
  • Proven ability to work with cross-functional teams comprised of internal and external contacts, including contract test labs
  • Ability to work a flexible work schedule to accommodate program priorities, international activities, and travel as needed
  • Previous experience with data trending and statistical programs (JMP, Excel, etc.) preferred
  • Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient