- Develop and manage timelines and budgets for AD scopes of work (SOWs) and activities consistent with corporate goals and needs.
- Work with business development and project management to prepare proposals for customers for analytical work which meet customer needs, have realistic timelines and are appropriately priced.
- Meet with customers to present plans and results of work done by the analytical team.
- Work with R&D and Regulatory Affairs to facilitate internal assay development and qualification for early phase programs in support of customer needs.
- Design, implement and report material comparability studies consistent with regulatory guidelines.
- Support Regulatory by compiling data, authoring and reviewing IND or similar sections as requested.
- Oversee all analytical development activities in compliance with International Conference on Harmonization (ICH) guidelines to support characterization of raw materials and AAV viral vectors and process-related impurities in support of preclinical and clinical pipeline programs
- Oversee assay transfer to QC or at contract testing organizations used for release testing of viral vectors used as raw material or final product in GLP animal and GCP human clinical studies.
- Work with QC/QA to ensure optimization and qualification/validation internally is successfully completed in support of clinical material testing and release and/or commercial advancement of relevant AAV therapeutic programs
- Manage direct reports, including setting individual goals and annual reviews aligning with corporate expectations.
- Other duties as assigned.
- This job description is subject to change at any time.
- Masters in a scientific or engineering discipline.
- PhD preferred.
- A Master's degree and a minimum of ten (10) years of experience, or PhD and a minimum of eight (8) years of experience. Experience must be in a biotechnology or pharmaceutical company AD/QC environment, gene therapy highly desirable.
- Strong experience/knowledge of assay development, including previous experience validating assays.
- Excellent organization and planning skills.
- In-depth understanding of regulatory requirements for the development, qualification and validation of assays employed in the release of human clinical material.
- Strong interpersonal skills and previous experience managing AD/internal QC analysts.
- Working knowledge of GLP, GMP, ICH and Quality Systems requirements for biologic products
- Excellent communication skills, both written and verbal
- Annual bonus
- 401k
- Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
- 20 days PTO
- 5 days Sick leave
- 6 weeks Parental Leave
- Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
- Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
- Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.
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Director, Analytical Development - Alachua, United States - Ascend Advanced Therapies
Description
The Director, Analytical Development (AD) is responsible for setting strategy for the analytical development function and executing the strategy to meet all applicable regulatory guidance. The Director will lead efforts to develop assays through transfer and validate assays for the characterization of viral vector biologics in support of the Company's product development projects. This includes both internal as well as with external vendors and contractors.
About Ascend:
Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.
Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Requirements
