Senior Director - Analytical Development
* Location: United States
* Work Arrangement: Remote
* Level: Senior Director
Our client, a highly successful and renowned biotechnology firm, stands as a pioneering force in the field of gene therapy. Driven by their commitment to improving lives, they lead the way in revolutionary breakthroughs. As the Senior Director of Analytical Development, you'll play a pivotal role in shaping the future of gene therapy innovations.
In the role of Senior Director - Analytical Development, you'll steer a team of analytical development directors, offering your expertise in drug substance and drug analytical development for gene therapies, primarily focused on AAVs. Your influence spans across all phases of drug development, with a special emphasis on mid-stage advancement. Your proficiency will be instrumental in driving the progress of drug development initiatives, significantly impacting patients' lives globally.
Responsibilities of the Senior Director - Analytical Development include:
* Crafting and executing a visionary analytical development strategy that aligns with our mission, propelling us towards a gene therapy revolution.
* Devising strategies for mid- to late-stage development within the drug product lifecycle.
* Utilizing your mastery in method development, validation, HPLC, LCMS, and GC to ensure the analytical precision of our gene therapy processes.
* Harnessing your expertise in molecular biology, PCR, ELISA, and assay development to steer the implementation of advanced gene analysis techniques.
* Leading cross-functional project teams to steer and execute CMC development plans.
* Collaborating with CMC and Quality teams to uphold cGMP manufacturing standards.
Qualifications for the Senior Director - Analytical Development:
* Over 6 years of experience working with viral vectors.
* 8+ years of experience contributing to CMC efforts from Phase I to Phase III (preferred).
* Bachelor's Degree with more than 14 years of experience, OR Master's Degree with over 12 years of experience, OR Ph.D. with more than 10 years of industry experience.
Company Perks:
* Competitive 401K program, comprehensive health insurance, and HSA accounts.
* Long-term incentives in the form of equity or stock at this level.
* Remote position for added flexibility.
If your passion lies in advancing gene therapy through analytical prowess and you thrive in leadership roles, seize this opportunity! Join us on this transformative journey by submitting your application today.
