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- 133 365 $ – 164 745 $
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Manager, Clinical Supply Chain
Привлекательная позиция в инновационной биотехнологической компании с конкурентной заработной платой и отличным социальным пакетом. Работа в современном производственном центре (The CLIMB) предоставляет отличные возможности для профессионального роста.
Сложность вакансии
Роль требует глубоких знаний в области GxP, управления сторонними логистическими провайдерами (3PL) и опыта работы в биотехнологической отрасли. Высокая ответственность за своевременную поставку клинических материалов делает позицию сложной и критически важной для компании.
Анализ зарплаты
Предлагаемая зарплата для уровня Manager ($133k-$165k) находится в верхнем диапазоне рыночных значений для Колорадо, что отражает высокую специализацию в области клеточной терапии. Уровень Senior Specialist также соответствует рыночным стандартам для опытных специалистов в биофармацевтике.
Сопроводительное письмо
I am writing to express my strong interest in the Clinical Supply Chain position at Umoja Biopharma. With extensive experience in managing clinical supply chains within cGMP environments and a proven track record of collaborating with Third Party Logistics (3PL) providers, I am confident in my ability to ensure the seamless delivery of life-saving therapies to clinical sites. My background in biotechnology and familiarity with ERP systems like NetSuite align perfectly with the requirements of your fast-paced manufacturing facility in Louisville.
Throughout my career, I have excelled at developing robust supply plans and mitigating risks in complex logistics networks. I am particularly drawn to Umoja’s mission of developing off-the-shelf immunotherapies and am eager to bring my expertise in clinical forecasting and distribution management to your team. I am a self-starter who thrives in start-up environments and is committed to maintaining the highest standards of compliance and operational excellence.
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Описание вакансии
Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
POSITION SUMMARY
Umoja Biopharma is seeking a Senior Clinical Supply Chain Specialist to join our fast-paced Supply Chain department located at our CLIMB cell/gene therapy manufacturing facility in Louisville, Colorado. This position will primarily support Clinical Supply Chain activities, including but not limited to working with Third Party Logistics providers to ensure on time and compliant supply of clinical material to clinical sites. This position will require a high level of accuracy, compliance, and planning.
This position may also assist in additional activities in support of Supply Chain at the Colorado Laboratory and Innovative Manufacturing Building (The CLIMB), including but not limited to shipping/logistics and Material Requirements Planning (MRP) support.
This role represents Umoja internally at multiple levels of the organization as well as externally with Third Party Logistic Providers. The Senior Clinical Supply Chain Specialist will work closely with Supply Chain, Clinical Operations, Quality, External Quality, Vendors, Finance, and the Warehouse teams. We are looking for a self-starter who brings their excellent communication skills, attention to detail, and ability to flex and pivot in an ever-changing start-up environment.
The successful candidate will have experience in managing Clinical Supply Chain activities, business workflow process and continuous improvement, clear communication with strong personnel skills to collaborate with and influence internal stakeholders, as well as proven ability to operate independently with limited direction on initiatives aligned with Umoja goals.
CORE ACCOUNTABILITIES
Specific responsibilities include:
- Clinical Supply Planning – develop supply plans and strategies to ensure on-time supply to clinical sites based on clinical forecasts, identify, mitigate, and resolve supply chain risks, issues, and recall support
- Logistics and Distribution – work with third party logistic provider to manage domestic and global distribution
- Third Party Logistic Provider (3PL) management – oversee label, pack, and distribution activities at 3PL, responsible for contract management, including contract approval, budget, and invoicing
- Compliance – ensure adherence to GMP regulations as required, generate and maintain applicable SOPs and shipment tracking
- Cross-functional collaboration – work closely with Clinical Operations, External Quality, Regulatory, and Finance as required
- Be a champion for policy, process, and compliance for all GMP-related procurement and clinical supply chain activities.
- Assist the Supply Chain Team with additional responsibilities in support of shipping/logistics and/or material resource planning as needed
The successful candidate will have:
- Bachelor's degree in science, engineering, business or a related discipline and a minimum of 8 years of relevant industry experience in business operations role, or an equivalent combination.
- Minimum of 5 years of clinical supply chain/supply chain, logistics, and/or operations-related experience in a cGMP environment.
- Working knowledge of Clinical Supply Chain activities and strategies.
- Experience working in a regulated manufacturing environment; pharmaceutical or biotechnology
- Detail oriented with the ability to identify and solve complex problems with minimum assistance.
- Self-motivated, pro-active, and able to work well both on a team and independently.
- Strong communication skills are a must.
Preferred Qualifications:
- Ability to multi-task in a fast-paced, matrix environment
- Experience with IRT systems for clinical supply management
- Experience with ERP systems, specifically NetSuite is highly desirable
- Working knowledge of ordering procedures, production planning, inventory replenishment methods, MRP, and ERP systems
- Strong Microsoft Office skills, working knowledge of Smartsheet
Physical Qualifications:
- Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
- Ability to perform physical tasks including standing, use of hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.
- Ability to work off hours, on-call, and/or weekends on occasion or in emergency situations.
- Ability to work onsite with flexibility to work from home as required.
Salary Range for Manager, Clinical Supply Chain: $133,365-$164,745
Salary Range for Senior Specialist, Clinical Supply Chain: $106,600 - $131,700
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.
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Навыки
- Project Management
- Supply Chain Management
- Logistics
- ERP
- Microsoft Office
- NetSuite
- Smartsheet
- MRP
- 3PL Management
- Clinical Supply Chain
- cGMP
- IRT Systems
Возможные вопросы на собеседовании
Проверка понимания специфики работы с термолабильными или специфическими биопрепаратами.
Опишите ваш опыт управления холодовой цепью при распределении клинических материалов. С какими основными рисками вы сталкивались?
Оценка навыков управления внешними подрядчиками, что является ключевой частью вакансии.
Как вы выстраиваете процесс контроля KPI и соблюдения комплаенса при работе с 3PL-провайдерами?
Проверка умения работать в условиях неопределенности, характерных для стартапов.
Приведите пример ситуации, когда клинический прогноз резко изменился. Как вы адаптировали план поставок, чтобы избежать дефицита?
Оценка технической грамотности и опыта работы с системами учета.
Каков ваш опыт работы с ERP-системами (например, NetSuite) и IRT-системами для управления запасами в клинических исследованиях?
Проверка знаний регуляторных требований.
Как вы обеспечиваете соблюдение стандартов GMP и GDP при подготовке документации для международных отгрузок?
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- Страна
- США
- Зарплата
- 133 365 $ – 164 745 $