Director of Process Chemistry (Biocatalysis)
Aralez Bio
San Leandro, CA, USA
Posted on Nov 5, 2024
About the Company
We envision a world where we continuously, sustainably, and affordably improve human life with synthetic biology. Our proprietary set of enzymes and our manufacturing approach enables the production of thousands of amino acids that were previously too difficult and expensive to make. These "noncanonical" amino acids that we make are already catalyzing the creation of revolutionary and innovative products that are good for people and the planet.
Our technology outperforms traditional manufacturing approaches by 10–100x across the board. We already sell products to Big 10 Pharmaceutical companies, and our product family includes the key components of multi-billion dollar blockbuster drugs such as Ozempic and Mounjaro.
We are a diverse, passionate, interdisciplinary team that finds joy in building something new that leaves the world better than we found it. We strive to always learn and improve and have a deep desire to capitalize on our creativity and be exceptional at what we do.
Job Summary
Aralez is growing! We are seeking a strategic, 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. Join a collaborative and mission-oriented culture where you'll have the ability to shape and lead a manufacturing department from the ground up.
Key Responsibilities
Leadership and Management:
This position will initially be based in our San Leandro, CA location and transition over to our new Berkeley, CA facility in the fall. - Aralez Bio may agree to offer relocation assistance for this role.
Benefits at Aralez Bio
Aralez Bio is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender, sex, and any other group protected under federal, state, or local laws.
We celebrate diversity and are committed to creating an inclusive environment for all employees. Please reach out if an accommodation is needed. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
We envision a world where we continuously, sustainably, and affordably improve human life with synthetic biology. Our proprietary set of enzymes and our manufacturing approach enables the production of thousands of amino acids that were previously too difficult and expensive to make. These "noncanonical" amino acids that we make are already catalyzing the creation of revolutionary and innovative products that are good for people and the planet.
Our technology outperforms traditional manufacturing approaches by 10–100x across the board. We already sell products to Big 10 Pharmaceutical companies, and our product family includes the key components of multi-billion dollar blockbuster drugs such as Ozempic and Mounjaro.
We are a diverse, passionate, interdisciplinary team that finds joy in building something new that leaves the world better than we found it. We strive to always learn and improve and have a deep desire to capitalize on our creativity and be exceptional at what we do.
Job Summary
Aralez is growing! We are seeking a strategic, 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. Join a collaborative and mission-oriented culture where you'll have the ability to shape and lead a manufacturing department from the ground up.
Key Responsibilities
Leadership and Management:
- 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.
- 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.
- 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.
- 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.
- 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 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.
- biocatalysis experience
- production of amino acids
- experience in a start-up environment
This position will initially be based in our San Leandro, CA location and transition over to our new Berkeley, CA facility in the fall. - Aralez Bio may agree to offer relocation assistance for this role.
Benefits at Aralez Bio
- Medical / Dental / Vision coverage
- Equity
- 401k
- Flexible Spending Account
- Unlimited time off policy
- Weekly catered lunch
- Professional Development opportunities
- Annual company retreat
Aralez Bio is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender, sex, and any other group protected under federal, state, or local laws.
We celebrate diversity and are committed to creating an inclusive environment for all employees. Please reach out if an accommodation is needed. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.