Head of Process Chemistry

2 weeks ago

San Leandro, California, United States Aralez Bio Full time
Job Overview

Company Overview

Aralez Bio is at the forefront of developing and producing noncanonical amino acids essential for creating groundbreaking products that benefit both individuals and the environment. Our innovative product line includes critical components for multi-billion dollar pharmaceutical successes.

Utilizing our proprietary enzyme technology, initially conceived in the lab of Nobel Laureate Frances Arnold, we streamline the synthesis of ncAAs, making it faster, more cost-effective, and environmentally friendly. Our advanced manufacturing methods significantly outperform traditional approaches, boasting efficiency improvements of 10 to 100 times. With the largest collection of noncanonical amino acids globally, we proudly serve numerous leading pharmaceutical companies.

We are a diverse and passionate team dedicated to innovation and sustainability, striving to make a positive impact on the world.

Position Summary

As we expand, Aralez Bio is looking for a strategic and proactive Director to lead our process development and manufacturing initiatives. Reporting directly to the CTO, the Director of Process Chemistry (Biocatalysis) will oversee process development, technology transfer, and manufacturing operations, ensuring the production of high-quality products in an efficient manner. This role will leverage enzymatic solutions to tackle complex chemical synthesis challenges, minimizing the use of hazardous materials and waste. Join a collaborative environment where you can shape and guide a manufacturing department from its inception.

Key Responsibilities

Leadership and Management:

  • Direct and manage process development, technology transfer, and manufacturing operations, ensuring compliance with ISO-9001 and other regulatory standards.
  • Lead and inspire the process development and manufacturing team, promoting a culture of safety, quality, and continuous improvement.
  • Formulate and execute strategic plans to enhance processes, boost efficiency, and lower costs.
  • Communicate manufacturing performance metrics, challenges, and opportunities to executive leadership and stakeholders.
  • Collaborate with cross-functional teams to facilitate product development, commercialization, and supply chain strategies.
  • Work alongside senior leadership to devise long-term manufacturing strategies that align with organizational objectives.
  • Recruit, mentor, and develop a high-performing manufacturing team.
  • Encourage a collaborative and inclusive workplace that fosters teamwork and innovation.

Technical Oversight and Risk Management:

  • Provide expert oversight in Process Development, managing both strategic and operational activities related to scale-up efforts.
  • Ensure manufacturing operations meet production timelines, quality benchmarks, and budgetary constraints.
  • Monitor production processes to ensure compliance with product specifications and regulatory standards.
  • Coordinate with R&D, Quality Assurance, and other departments to facilitate the seamless transition of new products to manufacturing.
  • Identify potential risks in manufacturing operations and develop strategies for mitigation.
  • Establish contingency plans to address production disruptions and emergencies.
  • Maintain comprehensive documentation and reporting systems for traceability and regulatory compliance.

Process Improvement:

  • Identify and implement enhancements to manufacturing processes to improve efficiency, product quality, and cost-effectiveness.
  • Drive initiatives for the adoption of innovative technologies and methodologies to advance manufacturing capabilities.
  • Establish and monitor key performance indicators (KPIs) to assess progress and guide continuous improvement efforts.

Operations:

  • Engage in business planning and forecasting to ensure manufacturing capabilities align with market demands.
  • Represent manufacturing functions during external audits, inspections, and regulatory submissions.
  • Develop and manage the manufacturing budget, ensuring optimal resource utilization.
  • Effectively allocate resources to achieve production goals and strategic objectives, overseeing procurement and maintenance of manufacturing equipment and materials.

Qualifications

  • Bachelor's degree in Chemistry, Chemical Engineering, or a related discipline.
  • 10+ years of experience in:
    • Designing and constructing infrastructure for pilot-scale production of synthetic chemical products.
    • Operating and scaling chemical processes for the production of amino acids, enzymes, active pharmaceutical ingredients, or similar products.
  • 5+ years of experience in team growth, including building, mentoring, and managing staff while balancing diverse responsibilities.
  • Demonstrated knowledge of lean manufacturing principles and continuous improvement methodologies.
  • Proven success in managing mid-to-large scale manufacturing operations.
  • Exceptional communication and interpersonal skills.
  • Ability to make data-driven decisions and resolve complex challenges.
  • Strong understanding of safety, quality, and regulatory standards in manufacturing.

Preferred Qualifications:

  • Experience in biocatalysis.
  • Background in amino acid production.
  • Experience in a start-up environment.

Compensation and Benefits

Aralez Bio offers a competitive salary range for this position, with additional benefits including:

  • Medical, Dental, and Vision coverage
  • Equity opportunities
  • 401k plan
  • Flexible Spending Account
  • Flexible time-off policy
  • Weekly catered lunches
  • Professional development opportunities
  • Annual company retreats

Aralez Bio is an equal opportunity employer, committed to fostering a diverse and inclusive workplace. We welcome applicants from all backgrounds and are dedicated to creating an environment where everyone can thrive.

In compliance with federal law, all individuals hired will be required to verify their identity and eligibility to work in the United States and complete the necessary employment eligibility verification form upon hire.

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