Operational Specialist
5 months ago
Hercules CA | On-SiteEntry Date: 15 JUNE 2024
X-Therma, a venture backed biotech company pioneers 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. Joining Team Excellence:We have a bold vision to create something great that has never been done before: We are wary of what could go wrong, but obsessed with what can go right. We are mission-driven, intellectually honest and relentless learners, ambitious, courageous, and extraordinarily persistent. “Giving up” does not exist in our vocabulary. We respect and support each other to get better every day and make the world a better place. We are in the San Francisco East Bay in Hercules, not only known for its beautiful scenery and comfortable weather all year round, but also you can truly embrace the breath of innovation and dream building spirit of San Francisco’s Biobay. X-Therma is 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. What’s in it for you?You will have a great opportunity to contribute to groundbreaking, life-saving products. You will be part of a team producing our novel life-saving molecules and solutions. This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities.
What you will do:
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.
- 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.
Requested Qualifications:
- 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.
- Will consider less experience for an Associate role
- 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.
- Intermediate skills with Microsoft Office Suite, Outlook, MS Teams, Smartsheet, and intranet/internet networks.
- Independent and fast learner capable of acting on brief instructions.
- 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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