Director Of Manufacturing Operations

DIRECTOR OF MANUFACTURING OPERATIONS

We are a biotech company that is commercializing enzymatically produced, proprietary technology as an alternative to plasmid-based DNA manufacturing processes with advantages of speed, purity and scalability to support the next generation of genetic medicines. Manufactured via a proprietary, large-scale PCR based platform, allows for rapid and efficient cell-free production of high-fidelity DNA sequences.

Position Summary:

We are seeking an experienced Director of Manufacturing Operations to oversee its enzymatic-based DNA manufacturing operations. This individual will be responsible for execution across various activities, including oversight of day-to-day manufacturing operations and to support a growing team with an increasing facilities footprint. In addition, this Director will contribute to our facilities strategy and ensure that the company's workplace is designed and operated in compliance with applicable quality management systems (ISO 13485 and cGMP), as well as training and team building, and preparing for inspection by customers and regulatory agencies. The ideal candidate will be a great team player with a proven track record in biopharma manufacturing operations with excellent organizational talent, outstanding communication skills, and effective management style.

Responsibilities:

• Oversee inventory, ensuring inventory levels are maintained appropriately, responding to usage changes and preparing for spikes in demand,
• Lead DNA production operations, facility/equipment/instrumentation, to serve the needs of onsite team members.
• Manage operational projects (e.g., space allocation, obtaining cGMP compliance and future facility search) and ensure day-to-day operations including supply management, shipping/receiving, instrumentation, scheduling and lab capacity utilization.
• Manage proficiency testing of staff.
• When needed, hire, and manage contractors or 3rd party vendors who are responsible for supporting manufacturing operations and instrumentation services.
• Lead the manufacturing team and guide the company’s manufacturing strategy and facilities buildout under ISO 13485 and cGMP quality systems.
• Serve as a single point of contact for site operations requests, executing on or delegating day-to-day tasks that need quick resolution.
• Engage with internal and external resources as needed to develop and successfully implement strategies and programs for managing ISO 13485 and cGMP compliance and risks, provide support to staff as it relates to use and storage of hazardous materials, and be the first point of contact for any safety issues.
• Support planning and procurement for lab equipment and supplies
• Partner with other functions to drive solutions for site needs.
• Provide administrative support to Senior management of APDN for board meetings and roadshows.
• Manage the ordering and upkeep of lab equipment, including purchases (price negotiation and installation), and facilitate interactions with equipment vendors for service calls and routine maintenance.
• Play a key role in managing critical aspects of facility build-outs and moves.

Qualifications:

• A deep passion for innovative science and a desire to make a clinical impact in the exciting field of genetic medicine.
• Knowledge of laboratory safety and associated regulatory guidelines, and experience in handling and managing laboratory chemicals and biological materials, chemical and reagent inventory systems.
• Expertise in nucleic acid manufacturing (DNA or RNA) preferred.
• Strong collaborator and committed team player, with exceptional organizational, record-keeping and communication skills, both verbal and written
• Ability to maintain professional and productive relationships with internal colleagues and external collaborators.
• 5+ years of experience executing and leading manufacturing facility operations in the biotech/pharmaceutical industry. Experience with ISO13485 and/or cGMP quality systems preferred.
• Comfort in a fast-paced, growth environment, with the demonstrated ability to oversee multiple workstreams and shifting priorities.
• Bachelor's degree in a scientific discipline or equivalent work experience. Masters or PhD in life sciences preferred
• Willingness to learn, teach, and grow in a fast-paced environment.