Role OverviewThe Director, Technical Operations (CMC) is responsible for providing strategic leadership and oversight of drug product development with a primary focus on oral solid dosage (OSD) formulations. This role is accountable for formulation development, process scale-up, validation, and lifecycle management, while ensuring reliable support of clinical and commercial manufacturing.
What You Will Do
Establish and execute CMC strategies for OSD drug product development and lifecycle management from early development through commercialization. Provide technical leadership for formulation development, including preformulation, formulation design, process development, scale-up, and validation.
Why It Might Be a Fit
Minimum of 12-15 years of relevant pharmaceutical industry experience in CMC with a strong focus on drug product development and OSD formulations. Demonstrated expertise in formulation development, process scale-up, validation, and commercial manufacturing support.
Requirements
- Bachelor's degree in Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline
- Minimum of 12-15 years of relevant pharmaceutical industry experience in CMC
- Demonstrated expertise in formulation development, process scale-up, validation, and commercial manufacturing support
- Experience in packaging and labeling development, including design, qualification, and lifecycle management
- Working knowledge of serialization systems and global regulatory requirements
- Proven track record of significant CMC contributions to successful regulatory submissions
- Proven leadership experience managing teams and influencing cross-functional stakeholders in a matrix environment
- Strong understanding of cGMP, ICH guidelines, and global regulatory expectations
- Experience working with CDMOs and external partners across global supply chains
- Strong project management, organizational, and problem-solving skills
- Excellent written and verbal communication skills with the ability to influence and drive decision-making
Benefits
- Salary range: $200,000 to $240,000
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