Director of Drug Product (GMP, Biologics, Lyophilization, and Fill/Finish Expertise)
Director of Drug Product (GMP, Biologics, Lyophilization, and Fill/Finish Expertise)
Department: Biotechnology
Location: Boston, MA
Position Type: Full-Time
Reports To: Chief Technical Operations Officer
Position Overview:
We are searching for a highly experienced Director of Drug Product with a strong background in GMP (Good Manufacturing Practices) manufacturing, process validation, lyophilization processes, and fill/finish operations for biologics. The ideal candidate will lead our drug product development and manufacturing efforts to ensure the highest quality standards and regulatory compliance in late-stage development to commercialization.
Key Responsibilities:
- Strategic Leadership:
- Develop and execute strategic plans for drug product manufacturing, process validation, and preparation for BLA submission, aligning with the company’s goals and objectives.
- Collaborate with cross-functional teams and CDMO to proactively identify risks and opportunities for optimization in drug product processes, manage potential quality and regulatory risks and develop solutions.
- Biologics Expertise:
- Oversee the production of biologic drug products, ensuring their quality, efficacy, and stability.
- Implement best practices and stay updated on industry trends in biologic manufacturing.
- Lyophilization and Fill/Finish:
- Manage lyophilization processes and fill/finish operations to maintain product integrity with oversight of the manufacture, testing, and release of clinical/commercial supplies.
- Address and resolve technical challenges related to lyophilization and fill/finish and develop plans for and execute process validation.
- GMP/Regulatory Compliance:
- Ensure all drug product activities adhere to GMP guidelines and regulatory requirements.
- Manage and author CMC/Quality sections of regulatory submissions (IND/CTD/BLA/MAA), technical reports, HA briefing packages, and responses to HA questions.Team Leadership:
- Foster a culture of excellence, collaboration, and continuous learning.
- Process Optimization:
- Collaborate with CDMO to design and implement scalable drug product manufacturing processes.
- Identify and implement efficiency improvements and cost-saving initiatives.
- Quality Assurance:
- Collaborate closely 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.
- Safety and Environmental Compliance:
- Promote a strong safety culture within the department, ensuring strict adherence to safety protocols.
- Ensure compliance with environmental regulations in drug product manufacturing.
- Documentation and 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, interface closely with Quality and Regulatory functions, and CDMOs to ensure compliance, science-based decisions, accuracy and completeness of technical documents and submissions.
Qualifications:
- Advanced degree in pharmaceutical sciences, biotechnology, or related fields preferred.
- Extensive experience in GMP-regulated drug product manufacturing and validation, with a focus on biologics, lyophilization, and fill/finish operations in CMC late-stage development within biotech/pharmaceutical industry.
- Experience in MBRs, EBRs, SOPs, GMP documents review and authoring relevant technical documents and CMC sections for IND/BLA submission
- Good understanding of cGMP, ICH, USP guidance and standards and FDA/EMA regulations relating to CMC and manufacturing for biologics.
- 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 highly advantageous.
Inozyme Pharma
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