Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Manages material needs/ requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Manufacturing Operations Management. Material Handlers must adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Required Competencies: Knowledge/ Skills, and Abilities:
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
- Background to include an understanding of biology, chemistry, medical or clinical practices is a plus
Duties and Responsibilities:
- Performs inventory control: cycle counts, material stocking, scrapping, at a minimum.
- Manages material expiry, allocation, kitting, and maintains material condition requirements.
- Quantifies and maintains materials in production dispensary.
- Performed apheresis receipt of incoming raw materials and prepares final product shipments for couriers.
- Maintains timing according to the production schedule to ensure on-time logistics.
- Records material handling data and information in a clear, concise, format according to proper GDPs.
- Works on a designated team in an assigned functional area.
- Must be able to work in an environment with blood derived components.
- Other duties may be assigned, as necessary.
- Performs other tasks as assigned.
Education and Experience:
- Bachelor’s degree
- OR Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience
- OR High School diploma/GED and 4 years of Manufacturing or Operations experience.
- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
- Physical dexterity sufficient to use computers and documentation.
- Sufficient vision and hearing capability to work in job environment.
- Ability to lift from 25- 50 pounds.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
- Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
- Routine exposure to human blood components.
- Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.