Associate Director, Sterile Drug Products
4 weeks ago
We are seeking a highly 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. The successful candidate will play a key role in vendor management and act as the subject matter expert for sterile drug products.
Key Responsibilities
• 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.
Requirements
• PhD in Pharmaceutical Sciences, Biotechnology, or related fields preferred.
• 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.
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).
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