Director of Facilities

NEUROTECH U S A•Cumberland, RI

12h•$180,000 - $205,000•Onsite

About The Position

Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech’s first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases. The Director of Facilities is responsible for managing the operations of Neurotech’s facilities inclusive of Environmental Health and Safety. The Facilities Associate Director/Director plays a vital role in the efforts of preparing the CGMP manufacturing facility for commercial launch by creating and managing facility related projects, timelines, and budgets.

Requirements

College graduate (BS degree) in mechanical or electrical engineering, architecture, facilities management, construction management, project management, building technology or related field with a minimum of 5-10 years of Industrial experience.
3+ years in a management role with strong skill sets in cGMP cleanroom facility management.
Must be able to work independently
Possess comprehensive knowledge of Common GMP utility systems (i.e. WFI, RODI, Clean Steam and HVAC).
Must have knowledge of CGMP cleanroom facilities design, operation, and/or computerized maintenance systems such as Metasys, Rees, Blue Mountain or equivalent systems
Must have experience writing, reviewing, and approving GxP documents (i.e. standard operating procedures (SOPs), User requirement specifications (URS), IQ/OQ/PQ, CAPAs, deviations, etc.)
Must have strong computer skills utilizing MS Office suite applications
Must have strong written and verbal communication skills
Possess a positive attitude and willingness to perform hands-on daily operations

Nice To Haves

Knowledge of EH&S programs/topics, state and local agencies and regulations a plus

Responsibilities

Oversee maintenance programs for all plant utilities and building infrastructure.
Manage contract service providers, including scheduling, coordination, and ensuring all work and documentation is performed in accordance with state/local and cGMP requirements.
Assessing and monitoring facility repairs to ensure cost effectiveness.
Implementing and monitoring all phases of preventative and corrective maintenance, construction, and project management while complying with budgetary constraints.
Assessing and monitoring facility equipment and operations including emergency standby equipment and operations to ensure optimum operation.
Monitoring emergencies; including equipment breakdowns, malfunctions, and alarm calls.
Development and improvement of facilities and engineering SOPs ensuring compliance with CGMP requirements.
Responsible for initiation and completion of deviations, CAPAs, and change controls for utility and building systems.
Direct and coordinate installation, operation, maintenance and repair of equipment, electrical, gas, air and/or water installation.
Develop and manage a robust operations and maintenance strategy, including preventative maintenance, spare parts inventory, and assess areas for continuous improvement.
Make recommendations to Senior Management to resolve maintenance issues and operations improvement.
Support validation activities as needed.
Read, redline, and manage engineering drawings and equipment files (P&IDs).
Provide project support and/or lead projects for the capital projects with design review, change control, commissioning, and turn over documentation close-out.
Ensure efficient and effective operation by creating a proactive maintenance environment, developing & monitoring metrics, regularly communicating with end users and maintenance personnel, monitoring & improving equipment reliability, and providing processes that utilize Maintenance & Reliability Best Practices.
Support Regulatory licensure activities, including agency inspections (i.e. DEM, Narragansett Bay Commission, Fire Department, and OSHA).
Prepare monthly management reports, including budget reporting.
Ensure appropriate training for all maintenance personnel on equipment, processes and facility procedures as applicable.
Manage the pest control program.
Oversee and manage the safety program for the site ensuring compliance with all regulatory agencies and ensuring that all staff is adequately trained. Update and maintain the SDS binders, chemical inventory list, and safety manuals regularly.