Job Description
ABOUT US
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!
JOB SUMMARY
The Head of Facilities will provide overall technical expertise and leadership to develop and implement the facilities and maintenance strategies for a new clinical cGMP manufacturing, warehouse, lab, and office facility located in Gainesville, FL. He/She is accountable for building, maintaining, and continuously improving a highly effective facilities workforce, driving activity to achieve the desired departmental, site, and company outcomes, and ensuring the highest standards of workplace safety and product quality are adhered to. The position oversees all aspects of the facilities management of Arranta's early process development and clinical GMP drug substance and drug product microbiome live biotherapeutic manufacturing facility, lab, warehouse, and office facilities in Florida, FL. The initial work will include the building of the systems, procedures and a team of skilled professionals to ensure a superior level of services in the areas of building systems, maintenance and repair, metrology, and custodial functions such as grounds and general maintenance. Specialty systems include the Building Management System (BMS), HVAC, water and specialty gas systems, alarm monitoring, emergency power and other critical systems to support a regulated laboratory and manufacturing environment.
ESSENTIAL RESPONSIBILITIES
• Identify and develop talent to produce a best-in-class team consistent with the Arranta mission and culture
• Development and maintenance of standard specifications and procedures for maintenance of plant mechanical and production systems and equipment. (Preventative maintenance programs, calibration program, etc. supporting facility start-up and ongoing continuous improvement).
• Collaborates with PD, Manufacturing, Quality for the execution of all equipment set-up, qualification, validation, maintenance, calibration, and metrology-related activities.
• Work closely with outside contractors to ensure that contracted maintenance services are performed to satisfactory specifications.
• Provides technical assistance and training to individuals to assure compliance with cGMP guidelines and written procedures.
• Promptly address plant/equipment challenges.
• Direct critical and facility equipment changes.
• Specify, review and approve purchases of equipment and service.
• Assist in specifying conceptual and detail design requirements for plant expansions and improvement projects.
• Direct the activities of maintenance, construction, and other vendor/contractors.
• Responsible for the annual Facilities Operational Budget. Is accountable for effective cost management and cost control, working proactively to maintain approved departmental and project budgets, and provide budgetary forecasts as required. Integrates budgets with the Chief Financial Officer
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
• B.S. in Engineering or related field
• 7+ years of related experience in a GMP setting
• Excellent communication skills, written and verbal
• Team player with the ability to influence others, inside and outside the organization.
• Ability to handle multiple priorities simultaneously
• Flexibility in problem solving
• Ability to work independently and cross-functionally in a dynamic environment.
• Strong time management and prioritization skills to manage multiple projects with critical, FDA enforced, deadlines and tight budgets.
• A broad understanding of Facilities-related subject matters is required.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle.
• Communicate using telephone and e-mail.