Director Analytical Development and Quality Control

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About This Opportunity

Location

Dartmouth, NS

Remote

Can work Remote

Department

Biotechnology and Pharmaceutical

Experience Level

Experienced

Employment Type

Full-time - Permanent

As Director of Analytical Development and Quality Control, you will leverage your expertise in analytical development, qualification/validation, and transfer and apply it to the compounds that make up IMV's lipid-based delivery platform (DPX) Drug Substance and Drug Products. In the near-term, focused on the advancement of IMV's lead asset, maveropepimut-S toward registration in ovarian cancer and hematological and other solid tumors. In this role, you will form close partnerships with internal stakeholders as well as CDMOs and third party laboratories.

Duties & Responsibilities

What you'll do

Drive analytical method development, qualification/ validation and product characterization.

Lead and manage a small, high performing internal AD & QC department.

Scope of technical responsibilities include analytical method development and transfer to support drug substance and drug product release (including cGMP biological potency assays), method development and transfer, qualification and validation, and generation and review of data to support drug substance and drug product release and stability during clinical development.

As a critical member of the CMC Team, and subject mater expert on analytical method and testing, responsible for leading the development and maintenance of specifications during clinical development.

Apply in-depth knowledge of analytical and pharmaceutical development to solve critical issues having a cross-functional impact.

Effectively interact with internal and external stakeholders and proactively communicate strategies and results.

Author regulatory submissions, respond to questions from health authorities and participate in meetings as needed.

Qualifications

What you'll need

Education:

Ph.D. degree in analytical chemistry, chemistry, biochemistry, or a related discipline,
7+ years of experience in the biotech or pharmaceutical industry or at an Analytical Development CRO. M.S. degree candidates with 10+ years of experience will be considered.

Experience:

Experience in Biologics and development of all release and stability analytical methods, including biological potency assays and drug product in-use characterization.
Have a broad and in-depth understanding of CMC, including phase-appropriate development amongst the different areas.
Knowledge of analytical requirements for intermediates, drug substance and drug products.
Direct experience with technology transfer within a company, to/from CROs/CMOs, and between international facilities a plus
In depth knowledge and thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development, manufacture, and stability.
Experience with authoring and reviewing regulatory submissions, responses to information request and developing briefing packages for technical meetings with regulatory authorities

Key Competencies and Skills

Expert knowledge of analytical method development, method validation, and characterization of drug substance and drug product.
Ability to assess technical data to provide oversight of technical reviews of analytical data, documents, and regulatory submissions.
Strong knowledge of cGMPs, including CMC regulatory information required for INDs/CTAs and BLAs/Biologic MAAs with respect to drug substance, pre-formulation, formulation, analytical methods, and dosage form manufacturing processes.
Strong attention to detail and excellent written and oral communication skills.
Strong leadership, coaching, and employee development skills.
Ability to work in a cross-functional team and matrix environment and influence others with or without authority at all levels of the organization.
Proactive with a true sense of urgency, innovative, and with good problem-solving skills.

Core Skills

We're looking for

CMC

ICH-GCP

FDA GMP

Team Leadership

Analytical Chemistry

Quality Control

A Little About IMV Inc.

IMV Inc. is a clinical-stage pharmaceutical company that has the potential to make history by developing a first-in-class effective T cell-targeted immune therapy for cancer. We have built an unprecedented delivery platform (DPX) that generates targeted immune cells directly into the human body, which produces robust, and sustained capabilities to destroy cancer. DPX is the engine that drives our lead drug candidate, Maveropepimut-S (DPX-Survivac), which has successfully completed multiple Phase 1/1b trials, generating best-in-class results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL).

Our Platform Enables a Strong, Sustained Immune Response

The unique "no-release" mechanism of action of our DPX Platform allows antigen-presenting cells (APCs) to be attracted to the injection site, facilitating antigen presentation to immune cells. All our immunotherapies and vaccine candidates are formulated with the DPX platform, giving them the ability to generate, in vivo, a targeted, robust, and sustained immune response against cancer cells or viruses.

Are You Interested?

Work with us

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. IMV 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.

Applications will be considered upon receipt.

*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.

Strong Science Needs Bright Minds

At IMV, 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. 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.

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