Associate Director, Sterile Drug Products & Vendor Management

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Job description

Position Overview:

We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor management and act as the subject matter expert for sterile drug products.

Reporting Relationship: This person will report to the Senior Director, Drug Product

About Inozyme Pharma:

Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).

Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.

Essential Duties and Responsibilities:

Strategic Leadership:

• Execute strategic plans for drug product manufacturing, process validation, and BLA preparation, aligning with company goals.
• Collaborate with cross-functional teams and CDMOs to identify risks and opportunities for process optimization, manage quality and regulatory risks, and develop solutions.
• Drive cGMP manufacturing timelines and product release milestones.

Sterile Drug Product Expertise:

• Oversee the production of sterile drug products, ensuring their quality, efficacy, and stability.
• Implement best practices and stay updated on industry trends in sterile drug product manufacturing.

Vendor Management:

• Act as primary point of contact for CDMOs and manage vendors for sterile drug product manufacturing day to day activities.
• Ensure effective communication and collaboration with vendors to achieve project goals and timelines.
• Act as person in plant during manufacturing campaigns. Travel to CDMOs for new project kick- off meetings and regular business review meetings.

Database Management:

• Develop and maintain comprehensive databases for sterile drug product development and manufacturing data.
• Ensure data integrity and compliance with regulatory requirements.

Process Optimization:

• Collaborate with CDMOs to design and implement scalable drug product manufacturing processes.
• Identify and implement efficiency improvements to maximize yields and cost-saving initiatives reduce DP cost of goods.

Quality Assurance & Regulatory Compliance:

• Collaborate with the Quality Assurance department to guarantee product quality and regulatory compliance.
• Prepare for and participate in regulatory inspections and audits, providing required documentation and support.
• Ensure all drug product activities adhere to GMP guidelines and regulatory requirements.

Documentation & Reporting:

• Maintain comprehensive and accurate documentation of all drug product manufacturing processes and development history/data.
• Prepare/compile/assemble technical reports and source documents for regulatory authorities as needed.
• Collaborate with cross-functional teams, Quality and Regulatory functions, and CDMOs to ensure compliance, science-based decisions, accuracy, and completeness of technical documents and submissions.

Travel Requirements:

• Ability to travel 10-20% of time to support external vendor activities.

Educational Qualifications: PhD in Pharmaceutical Sciences, Biotechnology, or related fields preferred

Additional Qualifications:

• Minimum 8 years of experience in GMP-regulated sterile drug product manufacturing and validation, with a focus on biologics, lyophilization, and fill/finish operations in CMC late-stage development within the biotech/pharmaceutical industry.
• Experience in MBRs, EBRs, SOPs, GMP documents review and authoring relevant technical documents and CMC sections for IND/BLA submission.
• Strong understanding of cGMP, ICH, USP guidance and standards, and FDA/EMA regulations relating to CMC and manufacturing for biologics.
• Proven experience in vendor management for sterile drug products.
• Experience with database management systems for scientific data.
• Strong leadership skills and a track record of successfully leading teams.
• In-depth knowledge of regulatory requirements and quality systems in the biotech/pharmaceutical industry.
• Excellent problem-solving abilities and the capacity to drive process improvements.
• Outstanding communication (oral, written, and presentation) and interpersonal skills.
• Experience with regulatory inspections and audits is a plus.

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