The successful candidate in this role will serve as the scientific and technical subject matter expert for biological assays and analytical ELISAs within Quality Unit of Immunovaccine. The main objective will be to work with internal analytical and technical subject matter experts and also from Contract Testing Organizations, as well as participate in analytical and technical projects, all related to biological assays, with particular focus on method transfers and qualification/validation. This position reports to the Quality Control & Analytical Development Manager.
What you'll do
- Acts as a Laboratory subject matter expert for testing including but not limited to Bioassay, Immunoassay, Cell Culture and Aseptic Technique.
- Assess Discovery based bioassay methods for their utility as potency assays for GMP product release and stability testing and that they are designed to meet current industry and regulatory guidance
- Evaluate and implement new technologies as required.
- Develop, implement and maintain procedures (SOP) that comply with appropriate regulatory requirements
- Leads transfers of suitable bioassays to third party laboratories and provide them with technical expertise, troubleshooting, training as required.
- Provide support to Research team throughout the on-going MOA assay development.
- Participate in the timely generation and/or review of trend data, investigations, non-conformances, validation protocols, reports in support of method validation/verifications.
- Ensure timely completion of Bio-assay related Laboratory Investigation Reports, deviations and non-conformances through QMS procedures
- Assist in product batch releases and stability study reports by reviewing biological assay test data to ensure conformance to specifications and input data (as applicable).
- Assists/performs internal/external (TPL’s) audits, if required.
- Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and biological assays.
- Authoring of relevant sections of regulatory submissions.
What you'll need
Minimum qualifications you must possess to be considered for this role:
- B.Sc. in a related science; Biology, Biotechnology, Biochemistry or a related discipline.
- 4-5 years experience in a QC pharmaceutical laboratory, preferably within a Bioassay lab.
Preferred qualifications for this role:
- 2-3 years experience in Microbiology release testing such as: endotoxin, bioburden, sterility testing.
- A strong background in validation of Bioassay and Immunassay for GMP use is essential.
- Strong knowledge and understanding of quality system regulations/ requirements (i.e. ICH Q4B, Q5C & D, ICH Q6B, ICH Q9, 21 CFR Part 210/211, Part 600/601/610, Part 820, cGMP/GLP or USP requirements).
- Excellent skills in teamwork and collaboration with international and external partner organizations.
- Ability to work in teams to obtain results by effectively influencing others, self-motivated/ directed, ability to organize activities, minimal supervision required.
- The successful candidate must demonstrate problem solving ability.
- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines.
- Attention to detail.
- Microbiology release testing, such as: endotoxin, bioburden, sterility testing experience is also desired but secondary to cell based assay experience.
- Broad experience with a variety of biological in-vitro systems.
- Previous experience in further developing R & D biological assays and/ or new technologies to get them ready for validation in a GMP environment will be a key asset in this role.
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 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 weekend work and/ or 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 occassionally for this position, when the succesful candidate will travel to our contract Manufacturing Organization and third party laboratories to support analytical activities. Inclusive of professional development opportunities, we expect approximately 5% 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 until the competition close date of October 31st, 2017 at midnight.
*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.)