Job Details

Process Engineer

Title
Process Engineer
Length
Full Time
Employer

IMV Inc.

Salary
not disclosed
Location
Halifax
Nova Scotia
Date Posted
04/07/2018 - 08:00
Closing Date
04/08/2018 - 08:00
Accepting BioReady
Yes
Job Description
Summary: 

Science and Research Experienced Full-time - Permanent

IMV Inc. is seeking an experienced Drug Product Engineer to work in its GMP Process Development department to support the company's sterile DepoVaxTM drug product development for clinical research and commercialization.

Responsible for sterile freeze-dried formulation process development to be implemented for cGMP production of product pipeline. The process engineer will develop and support GMP process development/method transfer to third parties (e.g., CDMOs and suppliers) including process performance monitoring; implementation of process improvement strategies; development of process models. Conduct in-house scale up formulation activities under the direction of the Director, GMP Process development. The ideal candidate will function within a team based organization to actively address complex cGMP process development/manufacturing issues. She/he will be expected to author and/or review protocols, technical reports, and regulatory submissions to support clinical development and licensure.

Education & Qualifications: 

What you'll need

  • 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.
  • We're looking for Core skills Multi Tasking Technical Writing Communication Skills Regulatory Affairs Process Improvement Scale Up Team Leadership Reports GMP Validation
Duties & Responsibilities: 

What you'll do

  • 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.
Other Information: 

A little bit about us

IMV Inc., formerly Immunovaccine, is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company's proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the reprogramming of immune cells in vivo,which are aimed at generating powerful new synthetic therapeutic capabilities. IMV's lead candidate, DPX-Survivac, is a T cell activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently conducting three Phase 2 studies with Incyte and Merck assessing DPX-Survivac as a combination therapy in ovarian cancer and diffuse large B-cell lymphoma. Connect at www.imv-inc.com.

Are you interested? Apply today!
https://jobs.careerbeacon.com/details/process-engineer/1273723?utm_sourc...

Work environment:

Our head office is on Summer Street in Halifax, Nova Scotia but we are relocating to Dartmouth, Nova Scotia in July 2018. The normal work week is 35 hours, core hours being 9 am - 5 pm. This role will very occasionally see weekend work and/ or extended hours depending on the project underway at the time.

Travel is not expected for this position.

Salary and Benefits:

This will be a salaried position. Please indicate clearly on your application your desired salary for this role.

Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position. Immunovaccine offers paid vacation, health/ dental plan, employee assistance program, stock options, annual bonuses and cost of living increases to eligible employees.

Please clearly indicate in your application how you meet the requirements for this role, and why you think you would be the best candidate for the role.

Applications will be considered until the position is filled

*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior-based assessments as part of the interview process.

** The successful candidate will be required to provide a Criminal Record Check before their start date.

IMV Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company's DepoVax™ platform, a patented delivery agent that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as part of a triple combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline, including innovative vaccines for respiratory syncytial virus (RSV), and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. (Connect at www.imvaccine.com.)