Director of CMC, Early Stage Development

Company: Evolvinc
Location: South San Francisco
Posted on: June 8, 2021

Job Description:

Position Overview

The Director of CMC, Early Stage Development  will  be responsible for providing direction and oversight of technical activities associated with drug substance and drug product development (process and product) in support of development of small molecule therapeutics targeting genetically defined, neurodegenerative diseases.   

Responsibilities:

• Plan and lead drug substance and drug product development via contract research and contract development manufacturing organization (CDMO) partners, from pre-clinical through clinical development. Scope includes pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability
• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early stage programs. Negotiate and obtain legal and corporate approval for service agreements and related statements of work for development activities with external partners.
• Collaborate with cross-functional team and external partners to deliver robust, scalable, and cost-effective manufacturing processes and drug product formulations that meet or exceed clinical target product profile on one or more programs
• Direct/oversee contract manufacturing, testing, packaging and labeling operations for the companys drug substances and drug products, initially in clinical trials. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations
• Participate in product development project teams as CMC functional area representative. Actively manages CMC projects, creating and providing comprehensive plans, project analysis, and status reports/dashboards to teams and senior management as required
• Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
• Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations
•  Maintain knowledge of current best practices of manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
• Support creation and/or review of CMC sections of regulatory submissions (i.e. IMPD/INDs/NDA), and responses to regulatory agency (i.e., FDA, EMA, etc.) questions.
• BS/MS or PhD in a relevant discipline
• A minimum of 10 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry
• Experience leading early stage development (from discovery to Phase 1) required.
• Technical expertise in process development, scale-up, analytical characterization and stability of oral solid, small-molecule, poorly soluble compounds.  
• Strong understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
• Hands on experience in product development including oral solid, solution, suspension, and/or semisolid products.
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions
• Excellent project management and leadership skills, with ability to lead multiple programs at the same time

      Demonstrated ability to work effectively in a fast-paced, team-oriented environment

• Excellent communication skills (interpersonal, written and verbal), and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
• Must be well organized, proactive, detail-oriented, mature and have a professional demeanor

Work Environment:

• This is a fast paced, small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally up to 20% is required

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Keywords: Evolvinc, South San Francisco , Director of CMC, Early Stage Development, Other , South San Francisco, California