Executive Director, CMC

Executive Director – CMC

InduPro, Inc. is bringing life‑changing therapies to patients through novel cell‑surface platform technologies.

We are seeking a highly‑motivated and collaborative Executive Director with strong leadership and technical skills to oversee CMC activities for our ADC programs, including cell line, drug substance, drug product, process development, analytical development, cGMP manufacturing, stability studies, and clinical packaging labeling and distribution. This role will serve as the main point of contact with CDMOs and work with cross‑functional teams from research, translational, operations, clinical, and finance to advance programs through the clinic.

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 and negotiate supply/technical agreements; identify contract analytical laboratory sites to support third‑party manufacturing
• Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products; act as primary liaison with contractors and guide external operations through tech transfer, process and method development, optimization, qualification and validation 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, material management, etc., in compliance with GMP
• Work with regulatory, QA, and senior management consultants to ensure company policies are adhered to and external manufacturing activities comply with relevant regulations
• Maintain knowledge of current best practices of biological manufacturing; identify emerging trends and technologies and lead feasibility assessment and implementation 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 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 as necessary 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
• Minimum 10 years of experience in CMC project management, development, scale‑up and clinical/commercial development of biologic products in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role
• Experience leading 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 preferred
• ADC experience preferred
• Hands‑on experience in more than one of the following CMC functions: drug substance, drug product, analytical development, process development, 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 preferred
• Team player able to think creatively and integrate perspectives from different functional areas
• Strong leadership skills with a 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 is required.

Benefits

• Medical, dental, and vision coverage
• Company‑paid life and disability insurance
• Supplemental life and disability insurance
• Voluntary accident, critical illness, and hospital indemnity insurance
• 401(k) plan with employer matching contributions
• Flexible spending accounts
• Employee assistance program
• Flexible paid time off
• 10 paid company holidays
• 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.

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