Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for the treatment of Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform delivers cell gene therapeutic factors for the treatment of this chronic retinal disease.

We are currently seeking to add a Facilities Associate Director/Director who will be responsible for managing the operations of Neurotech’s facilities inclusive of Environmental Health and Safety and Warehouse and Logistics. 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.

This role is additionally responsible for building inspection/condition assessment and the recommending/executing of repairs or upgrades of facilities or infrastructures, be the customer liaison or contact point for service issues, designing, developing and administering various programs (EH&S, PM/Cal Programs), recommending equipment selections, performing feasibility studies, and providing technical expertise. The Facilities Associate Director/Director will also participate in strategic planning, create efficiencies, assure quality and set policy or procedures (SOPs/Safety Manual) per state/local regulations.

Requirements

Job Requirements

• 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.
• Assess and monitor facility repairs to ensure cost effectiveness.
• Implement and monitor all phases of preventative and corrective maintenance, construction, and project management while complying with budgetary constraints.
• Assess and monitor facility equipment and operations including emergency standby equipment and operations to ensure optimum operation.
• Monitor 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 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 pest control program.
• Oversee and manage the safety program for the site ensuring compliance with all regulatory agencies and that all staff is adequately trained.
• Update and maintain the SDS binders, chemical inventory list, and safety manuals regularly.

Education & Experience

• 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 supervisory role with strong skill sets in cGMP cleanroom facility management.
  
  

Knowledge, Skills & Abilities

• Must have strong computer skills utilizing MS Office suite applications.
• Must be able to work independently.
• Must have strong written and verbal communication skills.
• 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 cGxP documents (i.e., standard operating procedures (SOPs), User requirement specifications (URS), IQ/OQ/PQ, CAPAs, deviations, etc.).
• Possess comprehensive knowledge of common biotech utility systems (i.e., WFI, RODI, Clean Steam and HVAC).
• Knowledge of EH&S programs/topics, state and local agencies and regulations a plus
• Possess a positive attitude and willingness to perform hands-on daily operations

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HAS & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. And that’s just the beginning.

Do you share our vision?

To apply, please send a copy of your résumé to talent@neurotechusa.com.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.