IMV is hiring for various positions
BioNova
Halifax, Nova Scotia, CA
37d ago

Responsibilities

Responsibilities include, but are not limited to :

  • Participate in the design, planning and implementation of clinical trials.
  • Develop and ensure adherence to clinical trial timelines.
  • Prepare, review and approve trial-related documents.
  • Manage and oversee clinical activities from the start-up to the completion of the trials.
  • Ensure proper communication of study progress to stakeholders.
  • Identify, lead and manage CRO and other vendors.
  • Responsible for the quality and compliance with protocols and study procedures and ensure audit readiness.
  • Collaborate in the development of clinical SOP and guidelines.
  • Communicate and support clinical investigators.
  • Participate in the Site Initiation Visits and oversight of CRAs activities.
  • Coordinate and manage the Investigational Product and clinical samples operations.
  • Participate in the analysis of clinical trial results.
  • Qualifications

    To be considered for this role, you must possess the following minimum qualifications :

  • Masters degree in biological sciences
  • A minimum of 3-5 years experience in clinical development with a minimum of 2 years in the management and coordination of clinical trials.
  • Strong understanding and knowledge of GCP and ICH guidelines.
  • Experience with CRO and vendor selection (RFP, Bid Defense) and management.
  • The ideal candidate will possess :

  • A Ph.D. in biological sciences
  • 5-10 years experience in clinical development with a minimum of 2 years in the management and coordination of clinical trials.
  • Required Skills :

  • Strong negotiation, communication and organization skills.
  • Detail oriented and ability to prioritize.
  • Show adaptability and empowerment.
  • Capacity to work under pressure and tight timelines.
  • Responsibilities

  • Work on several different projects and able to perform key responsibilities in a fast-paced, as well as in a team environment.
  • Develop robust formulations processes for lipid based protein / peptide sterile parenteral dosage forms
  • Write study proposals, execute experiments, prepare batch records and process development reports
  • Support scale-up and optimization of existing manufacturing process; technology transfer from R&D to production to meet timelines.
  • Provide technical information for the generation of change controls, change management, design, and implement changes.
  • Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and regulatory filings.
  • Plan and contribute to project-related scientific / technical activities (e.g., critical interpretation of data, write reports and presents work at group and department meetings)
  • Author or support technical documents writing / review for tech transfer to CMOs and for regulatory filing purposes.
  • Interact with API manufacturers, equipment vendors, CROs and CMOs as needed.
  • Maintain instruments, qualification / validation of critical GMP equipment, troubleshoot instrumental / experimental problems and order / maintain supplies.
  • Generate and update SOPs, review of batch records, process characterization reports, validation reports and investigation reports.
  • Monitor process performance; implementation of process improvement strategies; development of process models.
  • Provide process development expertise for clinical / commercial Drug Product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation.
  • Support commercial DP manufacturing operations with technical evaluation of NC / CAPA, scale up, validation, and technology transfer.
  • Troubleshoot issues with DP processing technologies and equipment. Conduct FMEA for DP operations and propose / implement appropriate CAPA.
  • Identify and implement operational opportunities for current and new sterile operations.
  • Responsibilities include leading cross-site teams to support the above activities, providing recommendations to management.
  • Qualifications

  • BSc / MSc / PhD. in either Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering, Pharmacy with 5-10 years experience in pharmaceutical / Biotechnology industry.
  • Preferred Qualifications is MSc. in Science or Engineering, will have 5+ years of experience in support of Clinical Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
  • Industry experience in developing sterile manufacturing processes for GMP drug products and carry out method transfer to CMOs.
  • Experience in peptide / protein based drug process development is highly preferred.
  • Proven experience in process development for liposomes based products is an asset.
  • Proven experience in the tech transfer, batch document review of CMC filing of at least 2-3 investigational products at FDA, Health Canada and / or EU.
  • Experience including statistical analysis and design of experiments, process characterization, scale-up, and / or technology transfer experience.
  • Hands on experience in operating / Trouble shooting and maintenance of C5 / C55 extruder, DLS particle size analyzer, Silverson homogenizer, bench top-
  • Freeze-dryer and other critical GMP process related equipment.

  • Experience in sterile filtration of protein / peptides, liposomes and aseptic filling are highly required.
  • Experience with scale-up operations and support pre-IND formulations.
  • Excellent communication skills.
  • Apply
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