Site Operations Specialist

2 months ago

Hercules, California, United States X-Therma Inc. Full time
About X-Therma Inc.

X-Therma Inc. is a venture-backed biotech company pioneering ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need.

X-Therma collaborates with renowned research institutions such as Lawrence Berkeley National Laboratory and Johns Hopkins University and is supported with significant funding from the US Department of Defense, National Science Foundation, California Institute of Regenerative Medicine, etc.

X-Therma technology greatly improves cold-chain logistics and is an FDA Breakthrough Device to end the organ waiting list in a long-overlooked market. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard.

Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing and allow "off-the-shelf" living medicines in this hyper-growth space.

About the Role

We are seeking a highly motivated Operations Specialist to contribute to our life-saving products from ideation to commercialization and ensure excellence in site operations.

This role involves assisting with daily, weekly, and regular operational tasks, developing, and implementing policies and procedures, managing procurement activities, and interacting closely with management, R&D teams, and external partners.

Key Responsibilities
  • General Operations
    • Assist the Director of Operations with daily management and operational requirements or issues.
    • Develop, implement, and support the communication of company operational policies, procedures, and environmental health and safety protocols.
    • Organize and facilitate recurring operations meetings, manage meeting invites, agendas, status reports, and capture minutes.
    • Track and follow up on task details, schedules, and related activities.
    • Support leadership in company operations matters, including personnel onboarding, facility schedules, and communications.
    • Support management of contract renewals and amendments.
  • Personnel Operations
    • Maintain a safe working environment by enforcing safety protocols and conducting regular inspections. Ensure compliance with all regulatory requirements including FDA, ISO, and GMP standards.
    • Assist in the training and development of new and existing operational procedures, policies, and best practices.
  • Cross-Functional Collaboration
    • This position is very cross-functional between operations, quality, warehousing, purchasing, etc.
    • Collaborate with various departments to improve business operations.
    • Performs other related duties as assigned.
  • Purchasing, Vendors, and Warehouse
    • Manage company asset inventories, purchasing procedures, requests, approvals, and system data entry.
    • Monitor inventory levels and reorder materials as needed.
    • Negotiate contracts, terms, and pricing with suppliers to secure the best deals.
    • Create and manage purchase orders, ensuring accuracy and compliance with company policies.
    • Coordinate with vendors for time-critical schedules, logistics activities, maintenance, and facility cleaning.
    • Monitor and track delivery schedules to ensure timely receipt of goods and services.
    • Maintain records of purchases, pricing, and other important procurement data.
    • Resolve any issues or discrepancies with orders and deliveries promptly.
    • Work closely with finance to ensure accurate and timely payment of invoices.
    • Continuously evaluate and improve procurement processes to enhance efficiency and reduce costs.
    • Source and evaluate potential suppliers and vendors, ensuring they meet quality and cost requirements.
    • Identify, evaluate, and select suppliers based on quality, cost, and reliability.
    • Maintain strong relationships with existing suppliers and develop new supplier partnerships.
    • Track and analyze procurement costs to identify cost-saving opportunities.
    • Develop and implement strategies to reduce procurement expenses.
Requirements
  • Bachelor's degree in Business Administration, Supply Chain Management, or a related field.
  • Minimum of 3-5 years of experience in procurement, purchasing, or a similar role, preferably in biotechnology, pharma, medical device, or similar industries.
  • Proven experience in developing and implementing operational policies and procedures.
  • Exceptionally well-organized with a strong ability to file and manage tasks on time.
  • Proven skills in facility operations and project management.
  • Proactive attitude, thriving in an early-stage environment.
  • Strong work ethic, analytical and problem-solving skills, organizational skills, and attention to detail.
  • Ability to work in an office setting and physically lift up to 50 lbs.
  • Prolonged periods sitting at a desk and working on a computer.
  • This is an on-site position.
Preferred Qualifications
  • Knowledge and experience in cGMP, preferably FDA and ISO 13485 requirements.
  • A self-driven, highly efficient, and outcome-focused attitude.
  • Team-oriented drive to contribute to improving organ transplantation and regenerative medicine.

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