Commercial Product Production / Manufacturing Manager
About the Job
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By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network?
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. We depend on the many generous contributions of time, blood, and money from the American public to support our lifesaving services and programs. At the American Red Cross, you will enjoy a collaborative work culture committed to the diversity of our people, programs, and services. If you share our passion for helping people, join us in this excellent career opportunity.
This position will be responsible for all aspects of cGMP operations for Commercial Cell Therapy Raw Material Manufacturing for a key Red Cross Cell and Gene Therapy Solutions client. This role will oversee the successful manufacturing of key commercial raw materials through the application of best-in-class manufacturing principles and processes. This role will provide technical and managerial leadership in all cGMP and cleanroom manufacturing-related areas of production responsibility, collaborate across multiple functional areas, and support related teams in the delivery of a commercial-grade key raw material for use in commercial cell therapies.
- Responsible for the management of laboratory staff and volunteers including, but not limited to, hiring, training, coaching, evaluating, and disciplining to ensure a well-qualified team and to enhance operational success and compliance. Serve as a resource for supervisors for complex technical issues.
- Responsible for management of Manufacturing and Transportation, if applicable. Ensure all functions are performed by all applicable regulatory policies and/or procedures and promptly to meet customer needs.
- Ensure compliance with state and federal regulations, regional policies, and procedures.
- Coordinate the implementation of new or revised tests, procedures, and equipment with SOPs, CFR, and OSHA regulations.
- Ensure laboratory training and annual competency assessments are completed in compliance with established guidelines in the ARC training system.
- May act as a trainer for department-specific curricula.
- Manage and evaluate workflow, distribution routes, and processes to ensure efficient and streamlined manufacturing processes to meet customer demand and required timelines in a cost-efficient manner.
- Participate in documenting, investigating, troubleshooting, communicating, and preventing recurrence of department problems, concerns, and complaints.
- Lead suspect product department investigations.
- May be responsible for tracking, trending, and analysis of laboratory data and the generation of reports.
- Perform supervisory review of documents.
- Serve as a departmental expert on the applicable computer systems.
- Responsible for the accuracy of computer and physical blood component inventories.
- Interpret and administer policies, processes, and procedures that may affect sections and subordinate units.
- B.Sc./M.Sc. in Biochemical Science/Microbiology/Immunology or related field is required
- Minimum of 5 years of combined experience in cGMP and cleanroom manufacturing, operations management, tech transfer, and process and equipment validation, with a strong preference for direct cell therapy experience.
- 3 years supervisory experience
- Experience in a growing environment and managing fast-paced changes and balancing day-to-day operational demands with the need to extend and improve horizon planning to be prepared for future growth.
- Good communication and computer skills are required.
- Knowledge of blood products and supplies and the ability to interact with diverse customers is required.
- Must meet state and CLIA requirements.
- Ability to use a wide variety of lab or medical equipment.
- Ability to use a personal computer and applicable software for sustained periods.
- Ability to work on a team.
As part of the world's largest humanitarian network, the American Red Cross places top priority on the health and safety of our employees, volunteers, blood donors, and those who receive our aid and services. Our commitment to public health is unwavering-both during the COVID-19 pandemic and year-round.
Apply now! Joining our team will provide you with the opportunity to make a difference every day.
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.
Interested in Volunteering?
Life's emergencies don't stop, and neither do American Red Cross volunteers, who represent more than 90 percent of our workforce to help prevent and alleviate human suffering. You can make a difference by volunteering in a position that appeals to you and allows you to use your unique skills and talents. The Red Cross relies on generous volunteers who give their time and talent to help fulfill our lifesaving mission.
Visit redcross.org/volunteertoday to learn more, including our most-needed volunteer positions.
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