Vice President, Chemistry, Manufacturing, and Controls (CMC)
At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
Seeking an outstanding leader in Chemistry Manufacturing and Controls (CMC) with extensive experience in manufacturing and advancing small molecules through clinical trials to approval. The ideal candidate is one who has been involved in all aspects of drug product (API) and drug substance (DS) manufacture and can direct and oversee CMC regulatory strategy for multiple products.
The ideal candidate must be an outstanding leader with a proven track record of strategic planning and successful execution in advancing molecules from pre-clinical manufacturing to late-stage clinical trials. The candidate must be experienced in all aspects of DP and DS manufacture including selection and management CROs/CMOs, manufacturing of API under cGMP conditions, development of formulation strategies, and implementation of analytical methods consistent with regulatory guidelines. This role involves strategic oversight in anticipating drug supply needs for both preclinical and clinical studies, along with managing supply chain and logistics in support of multiple clinical trials. In addition, the role requires authoring, reviewing and editing CMC regulatory submissions and quality documents. The successful candidate will execute plans for the release, validation and registration of API and DP as required by regulatory and ICH guidelines. The candidate must have strong organizational and communication skills, be capable of strategically communicating to upper management, summarizing data, and effectively communicating across functions. Finally, the candidate must be comfortable with, and thrive in, a fast-paced entrepreneurial environment which necessitates a hands-on approach at all levels.
Preferred Experience and Education:
Preferred Additional Skills:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory ofall duties, responsibilities, and qualifications required of employees assigned to this job.