Executive Director, CMC

Key Responsibilities

• Establish, manage and lead CMC strategy and execution for assigned programs for drug substances and drug products from pre‑clinical through commercial development with close attention to timelines and budget
• Select third‑party vendors, negotiate effective supply/technical agreements, and identify contract analytical laboratory sites required to guide and support third‑party manufacturing relationships
• Direct and oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products; act as primary liaison with contractors on assigned projects and guide external operations through tech transfer, process and method development, optimization, qualification and validation of all manufacturing activities in compliance with GMP
• Participate in product development project teams as the CMC functional area representative
• Support the creation of SOPs and guidelines related to production, planning, disposition, management, materials, etc. in compliance with GMP
• Work with consultants for Regulatory and QA, alongside 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 biological manufacturing, identify emerging trends and technologies, and lead implementation/feasibility assessment, as appropriate
• Design and execute the CMC development plan to support global submissions
• Prepare CMC regulatory filing sections (domestic and international) including Module 3 and review of supporting documentation
• Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
• Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives
• Provide comprehensive project analysis to senior management as required in the form of reports or presentations

Education & Experience

• 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 of biologic products in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role
• Experience in leading and direct management of research, process development, and manufacturing
• Extensive experience in leading biological process and analytical development
• Previous experience leading cross‑functional project teams, and familiarity with the drug development process, including transitions from pre‑clinical to clinical development
• Experience managing contract development and manufacturing (CDMO) partnerships strongly preferred
• ADC experience strongly preferred
• Hands on experience in more than one of the following CMC functions: drug substance, drug product, analytical development, process development, and stability, or program management
• Experience developing and manufacturing aseptic biologic products
• Experience authoring successful IND and IMPD CMC regulatory submissions
• Familiarity with small start‑up environments strongly preferred
• Team player able to think creatively and integrate perspectives from different functional areas
• Strong leadership skills with demonstrated track record of success
• Excellent oral and written communication skills
• Able to effectively balance technical program requirements with business needs

Physical Work Requirements

• Prolonged periods sitting at a desk and working on a computer

Travel Requirements

This position does not generally require travel. Physical presence at the InduPro worksite, or in the field, is required for this role.

Benefits

We offer a competitive total compensation package that includes stock options, a performance bonus incentive plan, a comprehensive benefits package, paid time off, and opportunities for professional development. Benefits include medical, dental, and vision coverage; company‑paid life and disability insurance; supplemental life and disability insurance; voluntary accident, critical illness, and hospital indemnity insurance; a 401(k) plan with employer matching contributions; flexible spending accounts; an employee assistance program; flexible paid time off; 10 paid company holidays; and access to voluntary auto, home, legal, and pet insurance.

Equal Employment Opportunity Statement

InduPro, Inc. is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability, or any other status protected by federal, state, or local law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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