Director/Sr Director of CMC Development

ESCAPE Bio, Inc., a privately held, clinical stage biopharmaceutical company, is developing precisely targeted, novel therapies for genetically defined patients with neurodegeneration. ESCAPE was founded to leverage the rapid acquisition of emerging knowledge about novel neurobiology and genomics. We have a diverse pipeline of novel and best-in-class small molecule therapeutics in major areas of unmet need.  We are building the leading neurodegenerative disease company focused on neurodegenerative orphan populations. ESCAPE has a strong investor base, experienced management team and has a pipeline of early-stage clinical development programs. Title will be contingent upon previous experience and level of expertise. 

Position Overview:

The Director/Sr Director of CMC 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 ESCAPE Bio’s small molecule therapeutics targeting genetically defined, neurodegenerative diseases. The position is based in ESCAPE Bio’s South San Francisco office. 

Responsibilities:                                                                                          

• Responsible for providing technical leadership and guidance across CMC development disciplines to all outsourced development and manufacturing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations
• Scope of technical responsibilities include pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability studies
• Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones 
• As an experienced CMC leader, provide options and contingencies to overcome technical challenges, timeline limitations, or changes to program goals
• Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations
• Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership
• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs.  Negotiate, obtain and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners
• Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s 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
• In collaboration with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials handling, and documentation; Ensure these Quality standards are followed at CDMOs
• Work with Regulatory, QA and Senior Management to ensure that all company policies are followed 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 correspondence (i.e., FDA, EMA, etc.).

Qualifications:

• Advanced Degree in Organic Chemistry, Analytical Chemistry, or Pharmaceutical Sciences
• 15 + years of pharmaceutical development experience with at least 5 years of CMC team leadership in the biotechnology or pharmaceutical industry
• Successful track record in leading CMC activities through transition from research to clinical studies, Ph1 to registration
• Technical expertise in process development, scale-up, analytical characterization and stability of oral solid, small-molecule, poorly soluble compounds
• Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions
• Proven leadership and cross-functional management of CMC programs.  Track record of successfully driving and managing programs, overcoming challenges and risks
• 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 independent

Work Environment:

• This is a fast paced, small organization with focus on achieving clinical success in neurodegenerative diseases. 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