VP, Drug Delivery and Formulation Development
Our client is a biotechnology company. They have asked us to assist them in their search for a VP, Drug Delivery and Formulation Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Designs strategies for developing formulations and drug products, including early process development and scale-up, for preclinical, and clinical studies.
- Is responsible for developing and executing innovative (LNP and non-LNP) drug delivery strategies, approaches and technologies.
- Assists in preparing technical reports, data summaries, nonclinical and CMC-related regulatory submission documents.
- Identifies relevant academic and industry collaboration partners, CROs, and state-of-the-art technologies to further develop the company’s platform and pipeline.
- Builds and maintains effective partnerships with internal and external key stakeholders and CROs to ensure high quality and on-time execution.
- Collaborates with multidisciplinary project teams to ensure project progression.
- Works with early research teams to develop fit-for-purpose early formulations to support in vitro and in vivo studies.
- Oversees the growing team including resource planning, budgets, staff development, and performance management.
- Must have a graduate degree in life sciences, chemistry, or related field with significant experience in the biotech/pharma industry. An advanced degree is preferred.
- Must be a natural self-starter with strong organizational skills and can thrive in a busy, fast-paced environment.
- Must be available to travel if/when needed.
- The demonstrated ability to lead, build and manage an innovative and collaborative team is required.
- Broad experience using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile is required.
- Requires a proven track record in LNP formulations from preclinical through late-stage clinical development.
- Extensive hands-on experience in the development of novel formulation technologies is required.
- Must have the ability to assess the formulation and process technologies landscape to effectively identify and implement enabling formulation technologies or unique delivery systems.
- Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE) is required.
- Experience as primary author of relevant sections of INDs and other regulatory documents is required.
- Must have strong analytical, problem solving and critical thinking skills.
- Requires excellent oral and written communication skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
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