Director/Senior Director, CMC, Drug Product Development
$148.5k/y-$257.4k/y
BioSpace
2 days ago
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OnsiteFull-timeSenior
Summary
BioSpace is seeking a Director/Senior Director, CMC, Drug Product Development to join their team in Indianapolis, IN. The role involves leading formulation development activities across multiple dosage forms and therapeutic modalities, focusing on digital solutions and tools in drug product workflows.
About the Role
As the Director/Senior Director, CMC, Drug Product Development, you will lead formulation design and development for parenteral and solid oral drug products. You will manage external manufacturing networks, author regulatory submissions, and ensure compliance with cGMP standards. Additionally, you will develop and implement digital solutions, evaluate modeling tools, and monitor industry trends to enhance drug product development processes.
About You
Required:
PhD in Pharmaceutical Science or related field (Chemistry, Chemical Engineering, Pharmacy).
8+ years of pharmaceutical industry experience.
3+ years of experience with in silico tools or AI/ML solutions in drug product development.
Preferred:
Experience with multiple therapeutic modalities (small molecules, biologics, peptides, oligonucleotides).
Knowledge of emerging modalities including cell & gene therapy, RNA-based medicines.
Strong analytical and problem-solving skills.
Experience with biotechs/emerging companies and/or early-stage development programs.
Benefits
Competitive salary range of $148,500 - $257,400.
Eligibility for a company bonus based on performance.
Comprehensive benefits package including medical, dental, vision, and prescription drug benefits.
401(k) and pension plans.
Flexible benefits including healthcare and dependent care flexible spending accounts.
Life insurance and death benefits.
Vacation benefits and well-being programs.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.