Job Details

Director, GMP Process Development

Title
Director, GMP Process Development
Length
Full Time
Employer

Immunovaccine Inc.

Salary
not disclosed
Location
Halifax Regional Municipality
Nova Scotia
Date Posted
12/01/2018 - 11:15
Closing Date
22/01/2018 - 11:15
Job Description
Summary: 

Halifax Regional Municipality, Nova Scotia | Science and Research | Management | Full-time

Immunovaccine is seeking an experienced scientist or engineer to lead the company’s DepoVaxTM delivery platform and be accountable for sterile freeze-dried process development used for cGMP production of product pipeline. The Director will initially work primarily to develop GMP process development/method transfer to third parties (e.g., CDMOs and suppliers), while also establishing the necessary lab, analytical capabilities and staff to manage projects in-house. The director will provide cross-functional support to early process development, quality control, analytical development, process analytics, regulatory Affairs and other functions. She/he will author and/or review protocols, technical reports, and regulatory submissions to support clinical development and licensure.

Responsibilities

  • Develop robust formulations and processes for exclusively lipid based sterile parenteral dosage forms.
  • Evaluate patents and develop non-infringement strategies.
  • Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines.
  • Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
  • Author technical documents including Process Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose.
  • Interaction with API manufacturers, CROs and CMOs as needed.
  • Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
  • Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
  • Review of batch records, process characterization reports, validation reports and investigation reports.
  • Lead in the development of new drug delivery technologies and products.
  • Keep current with regulations and technical knowledge.
  • Secure and provide adequate scientific formulation support to all assigned projects.
  • Interface with internal and external clients in project meetings.
  • Assist Business Development in preparation of R&D project proposals. Provide input on the technical feasibility and resources required of the project.
  • Provide cost and man-hour estimates associated with R&D project proposals.
  • Direct priorities for within the position.
  • Provide input on project planning.
  • Ensure all activities comply with OSHA, EPA, DEA and cGMP’s regulations.
  • Maintain detailed records of all work to ensure compliance of all product submissions to the requirements by government agencies.
  • Prepare and review CMC text for IND/IMPD and other regulatory filings.
  • Prepare and review master batch records, development pharmaceutics reports and other formulation documents.
  • Provide necessary training, direction and mentoring to junior staff to achieve the company goals.
  • Participate in the interview and hiring of quality individuals to fill needed roles.
  • Perform other tasks as requested by the Senior Director of Research and Development
  • Writing SOPs, programs, specifications and protocols necessary for laboratory operations
  • Assist VP, Product Development & Manufacturing in product development activities, writing technical reports and assisting with formulation development studies

Qualifications

Minimum Requirements:

  • 5-10 years experience role specific industrial experience with a M.Sc. or Ph.D. in Pharmacy, Chemistry or Biochemistry.
  • 10 + years of role specific experience, if a B.Sc.is the highest level of education attained.
  • Hands on experience in operating/ troubleshooting and maintenance of C5/C55 extruder, DLS particile size analyzer, Silverson homogenizer and bench top freeze dryer.
  • Experience in sterile filtration of liposomes and aseptic filling are highly required.
  • 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.
  • Proven experience in handling clinical supplies management which includes procuring and distribution of clinical kit components for at least 2-3 phase 1/II clinical trial products.
  • Operating experience in an early stage clinical to commercial environment, as well as contract development and manufacturing is mandatory.

Preferred skills & education:

  • Post-secondary diploma in Biopharmaceutical Process and Product Development
  • Experience in peptide/ protein based drug product development is highly preferred
  • Proven experience in liposomes based product development cycles, manufacturing and distribution of finished products.
  • Extensive understanding of cGMP antibody process development and production.

Core Skills

  • Forward Thinking
  • Experience in early stage clinical environments
  • Bench-top freeze dryer
  • Silverson homogenizer
  • DLS Particle size analyzer
  • C5/C55 extruder
  • Sterile filtration of lyposomes and aseptic filling
  • Demonstrated decision making and problem solving capability
  • Excellent communication and interpersonal skills
  • Passion for results

Immunovaccine Inc

Strong Science Needs Bright Minds

At Immunovaccine, we have high standards. And even higher aspirations.

Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation–the ultimate value-drivers upon which we, as a Company, rest.

We Work Better Together.

Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and the road less traveled here in Halifax. As it turns out, that does make all the difference.

Valuable Work

We aim high with our mission, so we expect high performance from our people. Whether you are evaluating T cell responses, coordinating clinical operations with our partners, or working with our investor base, we depend on you to help realize the full value of our organization. In turn, we value you, and what you can bring to our Company. We support you in enjoying life fully while working towards your professional goals. Above all, we cultivate the camaraderie that is the hallmark of our corporate culture.

Happy Employees Produce Strong Results.

Talk to us about joining the Immunovaccine team.

Work With Us

Work environment:

Our head office is on Summer Street in Halifax, Nova Scotia and we have an office in Quebec City, Quebec. This role will work out of our Halifax, Nova Scotia office. The normal work week is 35 hours, core hours being 9 am – 5 pm. This role will very occasionally see early mornings, weekend work and/ or extended hours depending on the project underway at the time. You will spend most of your day standing at the lab bench. Distance travel, in clusive of preofessional development, is expected to be only 5 - 10% for this position.

Salary and Benefits:

This will be a salaried position, depending on skill and experience. Please indicate in your application, your salary expectations and your availability for this position.

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, and annual bonuses.

If you feel that you are the best candidate for this position, please apply through the “Apply Now” button.

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 upon receipt and until January 22, 2018.

*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.

Immunovaccine 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.)

Apply Now: https://jobs.careerbeacon.com/apply/893862