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Associate Director/Director
2 months ago
We seek a highly motivated, creative CMC formulation professional at the Associate Director or Director level to join our CMC team. Your role will be crucial in working closely with internal discovery and development teams and external CRO/CDMO companies to drive programs into early and late clinical development. This position is responsible for formulation strategy design, process development, and manufacturing. The ideal candidate will have an in-depth understanding of all aspects of oral solid dosage and injectable formulations. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will be able to work on multiple programs within the company’s pipeline, which comprises potentially first-in-class approaches & novel-novel targets. We are committed to pushing the boundaries of what is possible in CMC formulation and looking for individuals who share this passion and drive.
Responsibilities
- Understand the development candidate’s physicochemical properties and target product profile to evaluate formulation options and design phase-appropriate formulations at different development stages.
- Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records.
- Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget.
- Plan and oversee drug product process optimization, GMP manufacturing, packaging, labeling, and stability testing activities.
- Track process development/validation history and manage CMC drug product-related documents supporting the life cycle of quality improvement and regulatory filing/updates.
- Work closely with a cross-functional team within and outside the CMC department to align with key stakeholders (CMC, Clinical, Quality Assurance, and Regulatory).
- Author and review CMC drug product-related sections for regulatory filing and annual updates.
- Stay current on industry trends and regulatory requirements to ensure the delivery of quality products under the cGMP environment.
- Prepare and communicate research results in both oral and written formats.
- Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.
Qualifications
- Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least ten years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications)
- Highly familiar with current formulation principles and industry practices.
- Extensive process development/ optimization, scale-up, and process validation expertise, emphasizing solid oral dosage forms.
- Experience with injectable formulations and modern enabling technologies is a plus.
- Track record of accomplishment in managing CMC drug product projects at early and late development stages.
- Ability to enable external CRO/CDMO to achieve project goals on time and under budget.
- Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment
