Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering high-quality products and services that meet the industry’s evolving needs. Our experienced team of experts works tirelessly to ensure every project is completed on time, within budget, and to the highest possible standards. Whether you need support with drug development, manufacturing, or regulatory compliance, Porton Pharma Solutions Ltd. has the expertise and capabilities to help you achieve your goals.
J-STAR Research, Inc. is a subsidiary of Porton that specializes in providing contract chemistry services to the biopharmaceutical and biotechnology industry. Our primary focus is resolving intricate chemistry problems relating to Active Pharmaceutical Ingredients and Intermediates in the preclinical and clinical development phases. We are adept in synthetic chemistry and process research services, which include Process Chemistry, Quality Control, Good Manufacturing Practice, Quality Assurance, Crystallization Research and Development, Solid Form and Polymorph Screening, Catalysis Screening and Enabling Technology, High Potent Compound Handling (HPAPI), Impurity Isolation and Structural Elucidation, and Preformulation and Formulation Research and Development.
We are currently seeking a dedicated and experienced Facility Operation Sr. Manager/Associate Director to join our team. The role is responsible for overseeing the efficient and effective operation of the organization’s facilities. If you are a proactive and results-driven professional with a passion for facility management, we invite you to apply for this exciting opportunity.
Prerequisites
- Experience within the pharmaceutical/biotechnology industry or CDMO industry is desirable, but not mandatory. The knowledge of high potency facility operation is plus.
- > 10 years of facility support and construction project management experience.
Responsibilities
- Responsible for managing and coordinating facility and construction projects, tracking and maintaining construction and facility related budgets, forecasting, schedules and planning.
- Develop and manage the site’s Capital Projects plan and budget
- Devise, implement and oversee infrastructure installations, modifications and expansions of laboratory, production and general facility areas.
- Establish and track facility and maintenance related metrics and maintain or exceed established KPI targets.
- Monitor, track and coordinate all corrective and preventative maintenance work activity and inspect/review outside contractor work and provide internal approval for payment.
- Maintain operations and ensure work is performed in compliance with all state and federal guidance and regulations, including but not limited to GMP, DEA, EPA, FDA, OSHA etc.
- Responsible for contributing to audit readiness and for participating in audits with customers, the FDA and other Regulatory Agencies, as needed.
- Work with internal stakeholders and 3rd party resources to develop and maintain preventative maintenance procedures and schedule for the maintenance for the facilities and related equipment in alignment with the facility lease agreement and J-Star requirements.
- Minimize reliance on outside 3rd party vendors and perform basic maintenance and repairs on electrical, mechanical, automation and utility systems by judicious prioritization with other activities.
- Liaison with the Landlord on facility-related issues. Work with outside contractors, Landlord, and township for building and process related construction projects.
- Superuser for the building automation system with the ability to make program and set point changes, add new devices to the system and program such changes.
- Read and understand blue prints and schematics. Create and edit CAD drawings.
- Contribute to writing and editing SOPs.
- Ensure that all EHS systems (eye wash stations, safety showers, sprinkler systems, fire alarms, etc) are fully operational.
- Participate in the on-call process for responding to emergency calls on nights, weekends and holidays.
- Provide Card key access oversight and programming.
- Work to assure Quality Assurance requirements and regulatory compliance are maintained.
Qualifications
- Proven track record of setting and meeting aggressive targets as related to safe, timely execution of objectives.
- Excellent written, verbal and communication skills.
- Ability to prioritize and manage numerous projects simultaneously.
- Ability to interact in an effective and appropriate manner with diverse population sets.
- Ability to communicate candidly, clearly and timely.
- Experience in working on, positively contributing to, and leading teams.
- Proficient in Microsoft®Office™, AutoCAD® and other job-related software and applications.
- Ability to perform the physical requirements of the position. Must be able to walk, stand, crawl, stoop, crouch, bend or reach above and below shoulders height frequently. This job requires frequent twisting and turning of the body and the use of both hands.
- Have thorough knowledge in the areas of Mechanical, Electrical, and Industrial Engineering, Technical Management, Project Management
Reporting Relationship
- Reports to the Chief Operation Officer
How to Apply:
- Applicants must be able to work legally in the U.S.
- Email resume to resumes@jstar-research.com. Include the job title of the position you are applying for in the subject line.