Senior Scientist, CMC

NervGen Pharma Corp.

jobsincanada.one

NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen’s lead drug candidate, NVG-291 is currently in a Phase 1 clinical trial. NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic targeting pathogenic mechanisms that interfere with nervous system repair. NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of demyelination, spinal cord injury, peripheral nerve injury, and stroke, through enhanced axonal plasticity, regeneration, and remyelination. The company’s initial target indications are spinal cord injury, Alzheimer’s disease and multiple sclerosis.

Our corporate values are Excellence, Commitment, Innovation, and Teamwork.

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 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.

We appreciate the interest of all candidates but only those individuals legally entitled to work in Canada, or the United States of America will be considered.

Job Type: Full-time

Salary: $80,000.00-$90,000.00 per year

Benefits:

  • Dental care
  • Extended health care
  • Life insurance
  • Vision care

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Bonus pay

Work Location: Hybrid remote in Vancouver, BC V5M 4X6

Apply Now
To help us track our recruitment effort, please indicate in your cover/motivation letter where (jobsincanada.one) you saw this job posting.

Leave a Reply