Senior Scientist, CMC

Description

NervGen is seeking a highly motivated and qualified individual for the position of Senior Scientist, Chemistry, Manufacturing and Controls (CMC). This role reports to the Director, Pharmaceutical Development and will be responsible in coordinating and participating in the management of CMC activities. Focus will be on drug substance (DS) with active participation in drug product (DP) and clinical supplies activities. As an integral member of the development team, the Senior Scientist actively contributes to CMC strategic planning and deliverables.

Location

On-site in the Greater Vancouver area or remote. NervGen’s head office is in Vancouver, Canada.

Responsibilities

  • Play a key role in the management of CMC activities.
  • Design and implementation of experiments for drug product development.
  • Contribute to strategic and technical input to CMC planning and scenarios.
  • Provide technical review of CMC documentation including (but not limited) to batch records, specifications, protocols and reports in the areas of manufacturing, QC testing and stability programs.
  • Manage shipping logistics of DS, DP.
  • Participate in the management of clinical trial supplies.
  • Assist in maintaining and participate in planning the CMC budget.
  • Preparation of high-quality CMC section of regulatory documents (ex. module 3, US IND; QOS, Health Canada CTA; IMPD, Europe)
  • Contribute to CMC sections of nonclinical and clinical study documentation (ex. protocols, reports).
  • Contribute to multiple cross-functional teams to provide CMC strategic and technical input.
  • Maintain knowledge of CMC industry regulations and regulatory documentation.

Experience/Qualifications

  • An advanced degree (MS or PhD) in organic chemistry, equivalent experience/education with BS may be considered.
  • 5+ years in the biotech/pharmaceutical industry, and background in successful coordination/management of CMC contractors.
  • Proven record of successfully completing deliverables to meet objectives, timelines and budgets for CMC projects (in particular drug substance).
  • Familiarity in drug substance manufacturing, experience in peptides preferred.

Knowledge, Skills and Abilities

  • Excellent written, verbal, presentation, and interpersonal communication skills.
  • A positive, professional, and proactive attitude, ability to establish strong, healthy relationships across company departments and on cross-functional and external teams.
  • Understanding of cGMP and CMC regulatory requirements (FDA/EMEA/Health Canada/TGA/ICH guidelines).
  • Excellent organizational skills.
  • Demonstrated ability to meet deadlines/goals and multi-task in a fast-paced work environment.

Work Environment

This is a high growth, fast paced, small organization. The ability to be productive in an intense work environment is critical. Willingness to “roll the sleeves up” and get involved in the work at all levels is key. Flexibility and ability to travel may be required.