Director, Engineering (RTP/North Carolina)

Location
Raleigh, NC
Posted
May 25, 2021
Required Education
Bachelors Degree
Position Type
Full time
Adverum Biotechnologies is looking for an experienced Director of Engineering for the new RTP commercial manufacturing facility. This individual will lead the development of the Engineering functions, including equipment support, equipment validation and automation at the site, as well as provide technical expertise for the build and design of the facility.  This individual will be a key member of the site leadership, providing technical guidance and strategy as well as help develop and lead the culture of the facility.  Additionally, this individual will support and manage a team which is in line with the business plan and budget and collaborate closely with both site leadership and key corporate functions at Head Quarters. 
 

What you'll do:
  • Build and manage a team of engineers with the diverse scientific and technical skills required to support, improve and troubleshoot complex systems
  • Create, improve, and effectively implement new strategies, processes, and systems to support commercial manufacturing and quality control labs.
  • Plan and direct all aspects of engineering, validation, and automation activities and projects to enable organizational compliance and decision making. 
  • Work closely with Quality and key site departments to implement and follow the required policies and procedures for system qualification, maintenance
  • Support engineering and automation needs of the manufacturing and quality control group  
  • Direct the user requirements, design process, and qualification activities for facility and equipment.
  • Be responsible for IQ/OQ/PQ and validation of facilities, manufacturing and lab equipment
  • Set automation standards for process and building equipment
  • Implement methods/systems/tools to analyze performance of process and facilities equipment
  • Initiate/lead improvement events, using lean tools, that reduce waste, improve quality and enhance performance
  • Provide models, forecasting, options and analytics for decision-making purposes
  • Manage the workplace teams optimizing individual performance, encouraging personal and department development and recognizing achievement. Regularly review staffing levels, performance, succession planning, training and recruitment. 
  • Assume budgetary responsibility for facility engineering costs including long range planning and annual operating plan development. Source and manage vendors as required for workplace and related activities. 
  • Other responsibilities may be assigned as needed 

About you:
  • A minimum 10 years of engineering experience in biotechnology, gene therapy a plus
  • A proven leader who motivates others to collaborate effectively and deliver outstanding operational and strategic results 
  • Thorough understanding of engineering systems in a cGMP environment, including, but not limited to work orders, calibration and lifecycle management, validation, and change control.
  • Strong knowledge of biologics manufacturing equipment, including bioreactors, TFF and chromatography skids. 
  • Knowledge of utilities systems, including but not limited to HVAC, WFI, clean compressed air, process gases, chilled water, boilers, and wastewater treatment.
  • Excellent communication and interpersonal skills including the ability to present to and influence peers and executive leadership 
  • Demonstrated performance in building and leading high-performing teams.
  • Demonstrates a broad understanding of clinical and commercial biopharmaceutical operations.
  • Possesses strength working with Building Management Systems, Equipment automation & controls.
  • Bachelor’s degree in engineering preferred (or equivalent experience). Master’s degree in business also desirable 



About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation