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Director, Apheresis Site Operations
Full Time
Los Angeles, California, United States (This job is on-site)
Sponsors work visa for candidates.
Job description
Scismic is supporting the growth of a biotech company that is accelerating personalized medicine research by partnering with patients and pharmaceutical companies to accelerate precision medicine R&D. It is an exciting time; this biotech company is growing quickly and needs the best team members to join them.
About the Role:
About the Role:
The company is hiring an experienced Operations Director to oversee the growth of our Apheresis products and centers. The ideal candidate will have current or prior strong leadership skills to support, motivate and educate the team. In this new role, you will be responsible to develop and execute the Leukopak business plan in alignment with the company's strategic plan. This role will have oversight of approximately 5 FTEs, and assist in the upcoming expansion of our donation centers to additional sites. This role will be expected to work onsite at our Los Angeles, CA Donor Center.
Primary Responsibilities:
Apheresis Operations Leadership
- Responsible for apheresis donor center operations including capacity planning, site utilization, and production goals
- Leads the successful implementation of new or add-on services while following operational and quality protocols
- Drive departmental and operational production goals, strategies and plans, defining and executing on implementation plans for donor center operations.
- Oversight of external apheresis vendors and partners to maximize efficiencies, minimize waste and costs, and ensure that goals are met with high quality
- Involved in expansion opportunities and may be responsible for implementation of new product lines including the setup of additional sites or partnerships.
- Works with leadership and operations team to identify and fulfill donor room staffing requirements and subject recruitment needs to perform collections to meet or exceed timelines and study goals
- Primary communications lead between the site and stakeholders and can communicate project status, deliverables, and risks to cross-functional teams.
- Works with the finance team to provide oversight of site financials including budgets, costs, and approval of site expenditures.
Donor Center Operations
- Oversees the donor center to ensure that the donor experience and care is excellent. Ensures safety and compliance standards are met or exceeded.
- Oversees day-to-day operations including site staff supervision that includes hiring, management, retention and development of staff including nurses and medical assistants.
- Ensures that the nurses. medical assistants, and other on-site staff are set up for success by eliminating bottlenecks and challenges as it relates to all visits and day-to-day operations
- Ensures that staff is performing all collection and screening procedures according to client and protocol requirements and SOPs in a timely manner
- Ensures that the donor scheduling, screening, and collection process are optimized to meet targets and implements process improvements and changes according to protocol
- Collaborates with Quality/Medical Director for technical, donor safety, and/or eligibility issues
- Works with the lead nurse to develop the staff schedules that include proactive shift management and donor visit appointment slot creation while optimizing for collections targets
- Creates a welcoming environment for donors to increase donor retention
- Performs other duties as assigned
Quality, Safety, Regulatory & Compliance
- Develops or supports the development of site SOPs, policies, and procedures
- Works with the quality team to ensure audit readiness and can provide on-site leadership and support during audits
- Ensures that all procedures/SOPs are followed by the staff and are in compliance with company standards and regulations.
- Maintains change control processes and accurate records, consistently identifying and implementing process improvements.
- Manages issues, risks, and recalls related to leukapheresis and cryopreservation.
- Stays updated on industry standards and regulatory requirements.
- Troubleshoot any site issues related to but not limited to process deficiencies, safety or compliance issues, supply chain problems, and/or capacity constraints and takes them through resolution in a timely manner.
- Coordinates GxP training and support documentation management.
- Maintains knowledge and techniques related to blood and apheresis collection.
Position Requirements:
- Bachelor's degree in life sciences or health administration or equivalent; MBA/MHA or equivalent is a plus
- 5+ years of donor center, clinical, or hospital administration that include leading, managing and motivating teams of nurses/RNs
- 5+ years of donor apheresis or therapeutic apheresis experience
- Experience with GMP compliance; Audit experience is a plus
- Clinical research experience and/or clinical laboratory experience is a plus
- Prior experience as a nurse/apheresis nurse is a plus that includes familiarity with apheresis equipment and processes
- Excellent communication skills, problem-resolution and decision-making skills in a fast-paced, high-volume environment
- Demonstrates exceptional professionalism and sense of responsibility and urgency at all times
- Start-up experience is a plus (hands-on, roll up sleeves, adaptable, flexible)
- Experienced leader of clinical and non-clinical staff
- Customer focused, with strong interpersonal skills, and the ability to build and maintain partnerships
- Strong problem-solving capabilities, and the ability to prioritize effectively
- Excellent Technology/Computer skills are a must (Salesforce, Google Suite, Microsoft Office products, including Word, Excel, Outlook, and PowerPoint).
- Understanding confidentiality and privacy regulations when working with patients/donors
- Background, Drug testing and state of CA immunization requirements for healthcare settings
- Knowledge of basic laboratory practices and instrumentation is preferred.
- Familiar with current regulatory requirements and blood banking (AABB) and HCT/P regulations and standards is preferred.
- Basic Life Support CPR certification preferred
- Ability to work at the Los Angeles, CA Apheresis Donor Site
- Ability to work Monday - Thursday, 6:00 AM - 4:30 PM
Salary:
- $150,000 - $180,000/yr + 20% annual performance-based bonus
The company is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.