The Vice President of Manufacturing will provide strategic, operational, and technical leadership to the Company, leading the manufacturing operations and working closely with all members of the Management Team. The Vice President of Manufacturing will report directly to the Chief Executive Officer (CEO) and will serve on the Management Team.
Responsible to safely lead Clinical and Commercial cGMP Manufacturing to consistently deliver high quality products on time, at competitive cost, and in compliance with global regulatory requirements. Partner with process development and quality leaders and other support groups to drive continuous improvement in safety, quality, compliance, delivery, and value.
What you'll do
- Responsible for the production of sterile freeze dried vaccine products (lipid based formulations) and support cGMP manufacturing operations compliant to FDA, EU & Health Canada at prequalified Contracting Manufacturing Organizations (CMOs).
- Manages CMO selection process, inspection, contracting and associated budgets.
- Responsible for compliance with all regulatory policies. Implements company policies consistent with Corporate requirements.
- Manages the forecasting and securing the GMP raw materials supply chain (US/Europe) for synthetic peptides, oligonucleotides and lipid mixtures for the manufacture of company’s clinical products
- Oversees the Clinical Trial Material supply management to support company’s clinical trials in US, Canada and Europe. Resource model, resource forecast, resource and budget monitoring, strategic planning during outsourcing the clinical kitting, labeling and distribution
- Accountable for delivering quality products in a timely manner at competitive cost to the Company.
- Responsible for defining manufacturing near-term and long-term strategic plans. Implements required actions and plan to deliver committed results.
- Champions a culture of continuous improvement that leverages lean manufacturing principles.
- Develops annual operating budget and executes all operational activities to meet or beat financial plan.
- Regularly interacts with leaders from Process Development, Quality, Clinical, and Research to resolve issues, drive improvement activities, and prioritize initiatives and resources.
- Should be able travel around (20%) to accomplish the company’s cGMP campaigns
What you'll need
Minimum qualifications you must possess to be considered for this role:
Minimum of a BS/BA degree in engineering or technical discipline. Master’s Degree or MBA is highly preferred.
10 years of experience in Biopharmaceutical/Pharmaceutical manufacturing leadership.
Extensive experience in CMC Project Management, Technology transfer, scale-up, process validation and clinical/commercial drug product development and manufacturing of sterile freeze dried vaccine products in the biotechnology or pharmaceutical industry.
Must have previous relevant experience leading manufacturing operations with a proven track record of success in leading cGMP manufacturing.
Preferred qualifications for this role:
- Master's degree or MBA is highly preferred.
- Ability to manage activities of CMOs in terms of clinical/commercial manufacture, regulatory compliance, timeline and cost control.
- Understanding of global cGMP regulations and quality management systems for pharmaceutical or biotechnology operations, including participation in regulatory inspections.
- Hands on experience managing CMOs, e.g., Phase 3 ready ness, scale-up, process validation, analytical method development, stability assessment, process development, lipid formulation etc.
- Good understanding of cGMP, FDA, EMA and ICH regulations and guidelines relating to CMC areas.
- Good knowledge in defining the relationship between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and effective use of process risk assessment tools (e.g., FMEA, FMECA), statistical analysis tools.
- Good understanding of Design of Experiments (DOE) and Process analytical technology (PAT) tools as part of QbD process application, preferably in sterile freeze dried drug product setting.
- Proficiency in analysis of scientific data and results with ability to review/present scientific documents including reports, publications and regulatory submissions
- Excellent interpersonal, influencing, and negotiating skills.
- Strong project management, organizational, planning and analytical skills.
- Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with external engineering/technical experts, and manage multiple priorities.
- Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
- Proven experience in managing the Freeze dry cycle optimization, sterilizing grade filter membrane optimization and validation for lipid based vaccine formulations is an asset
Experience in achieving regulatory approval of new drug products is an asset.
We're looking for
A little bit about us
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.
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.
Are you interested?
Work With Us
Our head office is in Halifax, Nova Scotia and we have an office in Quebec City, Quebec. This role can either work out of our Halifax, Nova Scotia office, or be a remote position, for the right candidate. The normal work week is 35 hours, core hours being 9 am – 5 pm. This role will potentially see extended hours depending on the project underway at the time. You will spend most of your time sitting in an office environment. Distance travel is expected for this position, inclusive of professional development opportunities, we expect a minimum of 20% of your time to be spent travelling.
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.
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 immediately upon receipt and the position will remain open unti the right candidate can be found. We are open to international candidates.
*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.)