Director, CMC Project Development
BioSpacea day ago
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OnsiteFull-timeSenior
Summary
AbbVie is seeking a Director, CMC Project Development to join their team in North Chicago, IL. The role involves managing clinical development programs and leading Chemistry, Manufacturing and Controls (CMC) teams to create and implement CMC strategies.
About the Role
As the Director of CMC Project Development, you will independently manage several complex clinical development programs using a matrix approach. You will lead CMC teams and Product Presentation and Device Strategy Teams, ensuring effective communication and collaboration among various departments. Your responsibilities include creating CMC development plans, managing project timelines and risks, and ensuring compliance with regulatory requirements. You will also mentor team members and support corporate initiatives.
About You
Required:
- Bachelor's Degree with at least 12 years of experience in relevant functions, or a Master's Degree with at least 10 years of experience, or a PhD with at least 8 years of experience.
- 3-8 years of working experience in a similar role or related CMC function.
- Excellent scientific writing and verbal communication skills.
- Good working knowledge of regulatory requirements and familiarity with scientific instrumentation and techniques.
- Deep knowledge of the pharmaceutical drug development process.
Preferred:
- CMC interdisciplinary experience and expertise.
- Strong negotiating, influencing, and leadership skills.
- Creative in implementing entrepreneurial thinking and making smart business decisions.
Benefits
- Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligibility to participate in short-term incentive programs.
BioSpace
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North Chicago, IL