Executive Director, CMC

United States·Cambridgeexecutive

OtherExecutive Director

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

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OtherExecutive Director

About InduPro

InduPro, Inc. is bringing life-changing therapies to patients through novel cell-surface platform technologies. We are defining and manipulating protein interactions beyond natural signaling paradigms. InduPro platforms integrate inherent protein proximity at the cell surface with the ability to manipulate protein pairings via induced protein proximity to create novel signaling pathways and logic gates. Our culture fosters innovation at every level.

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 and stability studies, and clinical packaging labeling and distribution. This role will serve as the main point of contact with CDMOs and work within a cross-functional team, including representatives from research, translational, operations, clinical, and finance departments to successful advance programs through the clinic. This is an exciting, high visibility role for a seasoned individual looking to make an impact in a startup company.

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. Identify contract analytical laboratory sites required to guide and support third party manufacturing relationships.

Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products. 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 compliance with GMP.

Participate in product development project teams as CMC functional area representative.

Support the creation of SOPs and guidelines related to the production, planning, disposition and 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 as needed.

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. At least 5 years of experience 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 is strongly preferred.

Team player that is 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.

Prolonged periods sitting at a desk and working on a computer

This position does not generally require travel.

Physical presence at the InduPro worksite, or in the field, is required for this role. At InduPro we believe that physical presence helps enhance collaboration, innovation, productivity, employee well-being, employee engagement, and Company culture.