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 has made a quantum leap in demonstrating significant extension of organ shelf-life from a few hours to a few days in collaboration with a World leading surgical team. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard. We are generating revenue in the Cell & Gene Therapy (CGT) field and are currently experiencing exponential growth of commercial partnerships with the top CGT developers. Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing (TAM $8.8B) and allow “off-the-shelf" living medicines in this hyper-growth space.
Recently, our technology was designated as a Breakthrough Device by the FDA.
Joining Team Excellence:
With respect for life, 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 near Berkeley, 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.
To strengthen our growing team in Richmond, we are looking for an Operations Manager (Laboratory and Facilities). This important role will take ownership for managing our overall facility operations in a broad perspective from facility planning and maintenance, process deployment and communications, employee onboarding processes and effectiveness, ensuring quality assurance hand-offs for operational compliance, and overall excellence across organizational processes. Maintains all aspects of internal and external building structure, equipment and strategic procurement plans. Works closely with Quality Assurance to ensure operational compliance. Important for this role is working knowledge and appreciation of medical device and chemical research, quality assurance in manufacturing and laboratory environments.
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:
- Work with executive leadership and teams across the organization to help define and deliver on strategic and operational development goals and objectives.
- Develops environmental health and safety procedures for facilities. These procedures include emergency action plans, disaster recovery, business continuity, and other related procedures.
- Ensure facility and operational compliance of all business components with local, state, and federal laws.
- Create and assist with detailed project plans, oversight of time-critical activities, and coordinated implementations and vendor logistics.
- Execute project tasks of all sizes with a mindset that nothing is too small or too big to tackle. This can include small tasks of IT support and weekly operations communications, to bigger tasks such as help with capacity planning and high-level business goals.
- Support IT Helpdesk as initial problem solving and escalation contact.
- Support the company’s SOP documentation library and technology assets.
- Assist leadership in all Company operations matters, which may include accounting, legal filings, NDA’s, procurement, vendor management and service level agreements, personnel onboarding, facility planning, process documentation and training, resource management, and any other activity considered an operation of the company.
- Make decisions with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results.
- Responsible for setting department objectives and deadlines.
- Works closely with Program Management team to organize and facilitate project tracking and recurring meetings, setting agendas, and capturing minutes.
Qualification:
- 3-5 years of relevant work experience in STEM-based companies (biotechnology, pharma, medical device, etc.) and similar roles.
- Individual who is exceptionally well-organized, extremely efficient, and gives high attention to quality of work.
- A self-driven, highly efficient, and output focused attitude; the personal ambition to put in occasional overtime and weekend hours as required.
- Proven planning and project management skills for management of teams, status tracking, and reporting of operations projects that lead to success.
- Working knowledge of architectural, electrical, and mechanical systems.
- Working knowledge of leases, contracts, and service agreement details.
- Comfortable interacting with stakeholders at all levels and influencing without authority as a true team player.
- Thrive in an early-stage environment with a proactive attitude; no task is too big or too small.
- A strong work ethic to deliver results within timelines.
- Strong analytical and problem-solving skills, organization and people skills and attention to details.
- Must be able to work in an office setting and observe laboratory settings without prohibitive limitations.
- Able to physically lift up to 50 lbs.
Other Skills and Abilities:
- Intermediate skills with Microsoft Office Suite, Outlook, intranet/internet networking, and security.
- Working knowledge of facility security systems such as badge readers and cameras
Exceptional candidates will have:
- Knowledge and experience in cGMP, preferably FDA and ISO 13485 requirements
- Experience managing operations in both large and small organizations.
- Deep personal drive to improve organ transplantation and/or regenerative medicine.
Our package includes:
- Competitive base salary
- Health, vision, and dental benefits, with high family coverage
- 401(k) savings plan
- Employee Stock Option Plan
- 5-Day marriage leave policy
- And more!
X-Therma is an Equal Opportunity Employer. X-Therma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.