• Job Type:Contract

Posted about 6 hours ago

Job Description:

• Manages cold chain and patient material receipt, release, dispensing, inventory, and shipping for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Supply Chain Operations Management.

• The position must adhere to regulatory requirements while performing job functions.

• Job duties are performed in alignment with CAR-T production schedules, may require weekend work.

• Communication and initiation of production deviations and assistance with quality investigations are required, as applicable.

• Overtime may be required at management discretion including on weekends.

Duties and Responsibilities:

• Records patient material handling / operations data and information in a clear, concise, format according to proper cGxP requirements

• Performs inspection and receipt of incoming patient materials per cold chain shipping requirements in coordination with defined specifications and in collaboration with Incoming Quality Control

• Performs inventory control: cycle counts, material stocking, scrapping, destruction

• Completes inventory / material transfer and movement within facility

• Manages material expiry, lot / batch control, allocation and maintains material condition requirements

• Maintains timing according to the production schedule to ensure on-time material transfers and availability

• Completes transactions within an electronic data management system, i.e. Oracle

• Performs inspection and receipt of incoming Apheresis and PBMC and prepares final product shipments for couriers

• Quantifies and maintains materials in production dispensary.

• Perform 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 in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.

• Must be able to work in an environment with blood derived components.

• Completes training requirements in accordance to defined schedule / curricula

• Periodically reviews and provides input on revisions to SOPs related to functional responsibilities

• Provides support for investigations and issue resolution

• Assists with resolution of inbound issues (receiving, suspect damages, shipment errors)

• Identifies process and performance improvement opportunities

• Collaborates cross functionally with Manufacturing, Quality, Materials Management, Process & Technology.

• Other duties may be assigned, as necessary

• Education and Experience (As Applicable)

• Bachelors degree and 3 years of applicable Pharma experience

• An equivalent combination of education, experience and training may substitute

• Must have a valid driver's license

Required Competencies: Knowledge, Skills, and Abilities

• Ability to work as team

• Intermediate written and verbal communication and mathematical skills

• Introductory Proficiency in MS Office applications

• Inventory control and management including lot / batch segregation, expiration dating, and temperature storage requirements

• Advanced warehouse management system experience

• Background to include an understanding of biology, chemistry, medical or clinical practices preferred, not required

• ERP experience preferred, not required

Physical Requirements:

• Must be able to work in a cleanroom environment and perform aseptic processing

• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

• Ability to crouch, bend, twist, and reach

• Physical dexterity sufficient to use computers and documentation

• Must be able to work in Lab setting with biohazards/ various chemicals/ strong magnets

• Ability to stand /sit/walk for long periods of time and work different hours of the day

• Ability to lift/ push/ pull 50 lbs independently

• Must be able to perform activities with repetitive motions

• Must be able to wear clean room garments and personal protective equipment (PPE).

• Must be comfortable being exposed to human blood components.

• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

• Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions.

• Reagents, chemicals, and exposure to sanitization agents are expected.

• Based on work assignment, may be recommended (or required) to have medical and visual screening testing in accordance with the company's Occupational Health Program

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

• Employees holding this position will be required to perform any other job-related duties as requested by management.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.