Director of Process Chemistry
3 weeks ago
Aralez Bio is a cutting-edge biotechnology company that specializes in the development and manufacturing of noncanonical amino acids. Our innovative products are designed to create innovative products that are good for people and the planet. With a proprietary enzyme platform, we unlock ncAAs by making their synthesis faster, cheaper, and greener.
Job Summary
Aralez Bio is seeking a strategic and hands-on Director to develop, build, and guide our process development and manufacturing capabilities. Reporting to the CTO, the Director of Process Chemistry (Biocatalysis) will be responsible for process development, tech transfer, and manufacturing operations, ensuring the efficient production of high-quality products. In this role, you will leverage enzymes to solve complex chemical synthesis challenges, eliminating the need for hazardous or costly materials while minimizing waste.
Key Responsibilities
- Oversee and manage process development, tech transfer, and manufacturing operations, ensuring adherence to ISO-9001 and other regulatory standards.
- Provide leadership and direction to the process development, tech transfer, and manufacturing team, fostering a culture of continuous improvement, safety, and quality.
- Develop and implement strategic plans to optimize processes, improve efficiency, and reduce costs.
- Communicate manufacturing performance, barriers, and opportunities to executives and stakeholders.
- Collaborate with cross-functional teams to support product development, commercialization, and supply chain initiatives.
- Work with senior leadership to develop long-term manufacturing strategies aligned with company goals.
- Recruit, train, and develop a high-performing manufacturing team.
- Foster a collaborative and inclusive work environment that encourages teamwork and innovation.
Technical Oversight and Risk Management
- Provide expert guidance across Process Development, overseeing both strategic and day-to-day activities around scale-up activities.
- Ensure that manufacturing activities meet production schedules, quality standards, and budgetary requirements.
- Monitor and control production processes to meet product specifications and regulatory requirements.
- Coordinate with R&D, Quality Assurance, and other departments to ensure seamless transfer of new products to manufacturing.
- Identify potential risks in manufacturing operations and develop mitigation strategies.
- Ensure contingency plans are in place to address production disruptions and emergencies.
- Maintain robust documentation and reporting systems for traceability and regulatory compliance.
Process Improvement
- Identify and implement process improvements to enhance manufacturing efficiency, product quality, and cost-effectiveness.
- Implement initiatives for the adoption of new technologies and methods to improve manufacturing capabilities.
- Establish and monitor key performance indicators (KPIs) to track progress and guide continuous improvement.
Operations
- Participate in business planning and forecasting activities to ensure alignment of manufacturing capabilities with market demands.
- Represent the manufacturing functional areas in external audits, inspections, and regulatory submissions.
- Develop and manage the manufacturing budget, ensuring efficient use of resources.
- Allocate resources effectively to meet production goals and strategic objectives. Oversee procurement and maintenance of manufacturing equipment and materials.
Qualifications
- Bachelor's degree in Chemistry, Chemical Engineering, or a related field.
- 10+ years of experience in the following areas:
- the design and build of the infrastructure for pilot-scale production of synthetic chemical products.
- operation and scale-up of chemical processes used in the production of amino acids, enzymes, active pharmaceutical ingredients, drug substance materials, key starting materials, or similar products.
- 5+ years of experience growing teams to include building, mentoring, and managing staff, with success in balancing work streams across a wide variety of responsibilities.
- Demonstrated knowledge of lean manufacturing principles and continuous improvement methodologies.
- Proven track record of successfully managing mid-to-large-scale manufacturing operations.
- Excellent communication and interpersonal skills.
- Ability to make data-backed decisions and solve complex problems.
- Strong understanding of safety, quality, and regulatory standards in manufacturing.
Nice-to-Have
- Biocatalysis experience.
- Production of amino acids.
- Experience in a start-up environment.
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