Director, Engineering (GMP Facilities)

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Director will support the manufacturing and process development organizations by developing and implementing end-to-end process and automated technology solutions, resulting in robust, sustainable, integrated manufacturing processes. These are expected to drive substantial improvements in Quality, Reliability, Process Capability, Cost, and/or Environmental Health and Safety.

The Director will interact with cross-functional teams to lead the development and implementation of a portfolio of advanced processes in pharmaceutical manufacturing environments. Key elements of this role include the development of innovative equipment and processes required to support manufacturing of client products, associated pilot process scale up and/or product transfers, as well as managing life cycle needs for existing manufacturing operations.

Key responsibilities include but are not limited to:

• Provide leadership in the global Process and Automation strategy and portfolio management. Direct internal and external engineering resources toward practical technical developments such as automation of product assembly and implementation of associated manufacturing support systems. Develop a robust and credo-based talent development and succession planning in alignment with functional growth strategies.
• Identify, source, and evaluate new technology applications to support capable and site-appropriate automated manufacturing processes for global applications.
• Formulate operational requirement specifications in collaboration with cross-functional teams across multiple sites.
• Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams. Ensure teams select, scale-up, and implement robust manufacturing processes to budget and schedule while maintaining compliance to comprehensive medical device standards. Ensure the use of design for manufacturing, mistake proofing, and quality controls to minimize patient and regulatory compliance risks.
• Prepare presentation materials to facilitate strategic decision making and approval of multi-site new technology portfolio strategies with Upper Management. Anticipates financial needs, quantifies budget to support project planning, and manages budget per forecast and schedules.
• Establish and apply a design and change review process to ensure robust manufacturing equipment design, validation, and timely implementation for new and existing processes.

Education & Experience:

• Bachelor's degree in Engineering is required; Master's Degree in Engineering, Engineering Management, Technology and/or Business Administration preferred.
• Minimum of 12 years of experience in designing and implementing automated equipment and processes, as well as significant experience in managing associated technical engineering functions is required.
• Extensive experience in hands on implementation and support of automation systems within a highly regulated cleanroom manufacturing environment is required.
• Extensive experience in compliance Regulations that apply to Quality, Regulatory Compliance (21 CFR Part 11), Environmental Health and Safety, as well as have knowledge of standards related to equipment design and implementation into global medical device manufacturing plants.
  

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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