Director, Cellular Therapy Manufacturing Operations

Job Description:

Why Choose Us?
As one of the nation's premier humanitarian organizations, the American Red Cross is dedicated to helping people in need throughout the United States and, in association with other Red Cross networks, throughout the world. When you join our team, you have a direct impact on a meaningful mission, and you can help save lives every day. If you share our passion for helping people, join us in this excellent career opportunity. Work where your career is a force for good.

We are committed to the diversity of our workforce and to delivering our programs and services in a culturally competent manner reflecting the communities we serve. Our work environment is collaborative, respectful, and inclusive with a focus on building allyship and a culture of belonging that empowers all team members. Come to learn, grow, and succeed while sharing your passion for making a difference.

The Red Cross supports a variety of cultural and community resource groups for employees and volunteers. From the Ability Network, our Asian American & Pacific Islander Resource Group, the Latino Resource Group, and Red Cross PRIDE, tothe Umoja African American Resource Group, our Veterans+ Resource Group, and the Women's Resource Group, these networks provide connections, mentoring and help give voice to important concerns and opinions.

At the American Red Cross, your uniqueness can shine!

OUR IDEAL CANDIDATE:

Responsible for serving as a technical expert on cellular therapy manufacturing operations, both within American Red Cross (ARC) and in our work with hospitals, biotech, and pharma companies. Provide direct manufacturing operational oversight of the cellular therapy lab(s). Apply knowledge of transfusion/transplant clinical biology/biochemistry and hematology as applied in cell and gene therapy process and operations. Act as a facility, equipment, logistics, and product subject matter expert for cellular therapy labs within the Red Cross. Provide consultation to internal customers and external vendors. Lead and participate in cross-functional initiatives to advance ARC's provision of cellular therapy lab services to hospitals, biotech and pharma companies, and patients. Maintain knowledge of and perform duties in compliance with regulations outlined in the applicable Code of Federal Regulations (CFR) and other industry standards (such as Foundation for the Accreditation of Cellular Therapy and American Association of Blood Banking).

WHERE YOUR CAREER IS A FORCE GOOD:

• Provide direct operational oversight of the cellular therapy lab(s). Manage a team including hiring, training, coaching, evaluating and managing performance. Manage resource allocations and oversee staff training and assignments.
• Collaborate with other ARC and client stakeholder departments such as Quality Assurance and Supply Chain to ensure that the cellular therapy labs are compliant with all federal/state/local regulations, applicable accreditation agencies (e.g., FACT), and both client and ARC policies/procedures as applicable. Partner across organization to ensure alignment between operational capabilities and client demands.
• Plan and implement protocols related to manufacturing for research, clinical development, and commercial cell-based products requiring cell isolation and cryopreservation.
• Manage and operate ISO 7 cleanroom capabilities according to standard operating procedures. Ensure execution of manufacturing contracted products and services.
• Provide oversight of liquid nitrogen (LN2), dry ice, and network cryogenic storage capabilities. Optimize cryogenic logistics, develop a suite of analysis tools and establish relationships with air and ground freight providers serving local, domestic, and international destinations. Work with internal partners to accomplish goals.
• Oversee procurement, warehousing, and logistical activities in line with budgetary and procedural needs throughout the lab network. Communicate budget expenditure resulting from continuous process and manufacturing improvements. Ensure all revenue is effectively captured.
• Serve as a technical resource for other cellular therapy Labs throughout the ARC system, including serving as a subject-matter-expert at industry conferences and hospital seminars.
• Standard Schedule: Monday - Friday

The salary range for this position is $145,000-$160,000

This job will be posted for a minimum of five business days and extended if the applicant pool needs to be expanded.

• Note that American Red Cross salaries are aligned to the specific geographic location in which the work is primarily performed. Other factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role.

WHAT YOU NEED TO SUCCEED:

• Bachelor's degree in Life Sciences, Operations Management, Medical Technology, or a related field required.
• Minimum 7 years of related experience or equivalent combination of education and related experience required Experience with external client facing activity preferred.
• Demonstrated experience with quality systems and analysis responsibilities.
• 5 years of management experience.
• Ability to work on a team.
• Contract manufacturing experience preferred; knowledge of clinical microbiology is a plus.
• Knowledge of sterile manufacturing processes and regulatory requirements (FDA, cGMP, etc.).
• Strong interpersonal and verbal and written communication skills, with the ability to work independently as well as effectively engage and influence stakeholders at all levels, including staff, clients and physicians.
• Ability to prioritize and to deal with irregular flows of work volume.
• Working knowledge of tissue culture techniques, flow cytometry, sterility testing, and/or NAT-based assays preferred.
• Travel: Up to 10-15% travel may be required. Travel and conference participation is required to remain current in practice.

WHAT WILL GIVE YOU THE COMPETITIVE EDGE:

• PhD preferred.
• Biologics industry, blood banking, pharmaceutical/chemical manufacturing, or other related experience preferred.
• FDA and CLIA compliance understanding and experience.

BENEFITS FOR YOU:

We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the American Red Cross to advance and learn.

• Medical, Dental Vision plans
• Health Spending Accounts & Flexible Spending Accounts
• PTO + Holidays
• 401K with 6% match
• Paid Family Leave
• Employee Assistance
• Disability and Insurance: Short + Long Term
• Service Awards and recognition

The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, San Diego Fair Chance Ordinance, the California Fair Chance Act and any other applicable state and local laws.

AmeriCorps, the federal agency that brings people together through service, and its partners - the Peace Corps, AmeriCorps Alums, National Peace Corps Association, and the Service Year Alliance - launched Employers of National Service to connect national service alumni with opportunities in the workforce.American Red Cross is proud to be an EONS partner and share our employment opportunities with the network of organizations.

Interested in Volunteering? Visit redcross.org/volunteertoday to learn more, including our most-needed volunteer positions.

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