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:

1. Strategic Leadership:
2. Develop and execute strategic plans for drug product manufacturing, process validation, and preparation for BLA submission, aligning with the company’s goals and objectives.
3. 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.

1. Biologics Expertise:
2. Oversee the production of biologic drug products, ensuring their quality, efficacy, and stability.
3. Implement best practices and stay updated on industry trends in biologic manufacturing.

1. Lyophilization and Fill/Finish:
2. Manage lyophilization processes and fill/finish operations to maintain product integrity with oversight of the manufacture, testing, and release of clinical/commercial supplies.
3. Address and resolve technical challenges related to lyophilization and fill/finish and develop plans for and execute process validation.

1. GMP/Regulatory Compliance:
2. Ensure all drug product activities adhere to GMP guidelines and regulatory requirements.

1. 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:
2. Foster a culture of excellence, collaboration, and continuous learning.
3. Process Optimization:
4. Collaborate with CDMO to design and implement scalable drug product manufacturing processes.
5. Identify and implement efficiency improvements and cost-saving initiatives.

1. Quality Assurance:
2. Collaborate closely with the Quality Assurance department to guarantee product quality and regulatory compliance.
3. Prepare for and participate in regulatory inspections and audits, providing required documentation and support.

1. Safety and Environmental Compliance:
2. Promote a strong safety culture within the department, ensuring strict adherence to safety protocols.
3. Ensure compliance with environmental regulations in drug product manufacturing.

1. Documentation and Reporting:
2. Maintain comprehensive and accurate documentation of all drug product manufacturing processes and development history/data.
3. Prepare/compile/assemble technical reports and source documents for regulatory authorities as needed.
4. 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