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Analytical Development Scientist

Corbus Pharmaceuticals

Analytical Development Scientist

Norwood, MA
Paid
  • Responsibilities

    Job Description

    The Pharmaceutical Development & Manufacturing function of Corbus Pharmaceuticals is currently seeking an experienced analytical chemist to direct, oversee and support method development and validation for chromatographic and characterization techniques carried out at our contract development and manufacturing organizations (CDMOs). Corbus is a virtual company that is focused on developing novel enabling science, exceptional processes and disruptive innovation in the pursuit of safe, efficient, green, and industry leading manufacturing routes to Corbus assets. Cross-functional collaboration and a mind-set of innovation and growth are critical to this role. Our department offers an excellent opportunity to those who want to learn and grow their career while continuing to develop our shared culture of excellence. This position is not lab based.

    THE CANDIDATE WILL POSSESS:

    • Hands-on experience developing, troubleshooting, and validating analytical methods for small molecule drug substance or drug product testing including authoring protocols and reports
    • Experience performing method transfers including setting acceptance criteria and drafting transfer protocols and reports
    • Direct experience performing chemical testing of raw materials, intermediates, drug substance, and drug products
    • Working knowledge of common analytical techniques such as: HPLC, GC, UV-Vis, Dissolution, KF, FTIR, NMR, and physical characterization methods
    • Experience with following Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)
    • Experience performing GMP review of raw data and analytical reports
    • Excellent interpersonal, verbal, and written communication skills

    KEY RESPONSIBILITIES:

    • Member of a cross functional CMC team to support development of small molecule drug candidates
    • Support analytical development and validation activities at CDMOs include review of development data and summary reports
    • Evaluate data to ensure compliance with analytical methods, specification criteria, and GMPs
    • Contribute analytical expertise to process development and manufacturing of regulatory starting materials, drug substance and drug product
    • Review and trending of stability studies and data analysis
    • Management of external reference standard qualification and inventory
    • Prepare high quality written reports and assist in preparing regulatory submissions
    • Proactively ensure high quality of work and demonstrate initiative to take on new responsibilities
  • Qualifications

    Qualifications

    MINIMUM QUALIFICATIONS

    • B.S. in Chemistry or equivalent with a minimum of 5 years relevant experience in a GMP environment or a M.S. in Chemistry with a minimum of 3 years relevant experience in a GMP environment

    • Expertise in current instrumentation and analytical techniques
    • Knowledge of industry guidances, federal regulations, and pharmacopeia
    • Comfortable in a fast-paced environment and able to adjust based on changing priorities
    • Excellent organizational and critical thinking skills and ability to function cooperatively and effectively in a team environment
    PREFERRED:
    
    
    • Prior experience directly collaborating with contract research organizations (CROs) and contract manufacturing organizations (CMOs)
    • Practical knowledge of DSC, TGA, XRPD, PSD, LC-MS, and ICP-MS
    • Experience authoring or reviewing OOS investigations, deviations, and CAPAs
    • Familiarity with stability study management and stability management software
    • Hands-on experience with analysis of oral solid dosage forms, including dissolution, blend uniformity and content uniformity
    • Prior experience with bioanalytical methods a plus

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

  • Industry
    Biotechnology