Sr Clinical Manufacturing Associate, Cell Therapy - Devens MA

Military Spouse Corporate Career Network•Devens, MA

1d•Onsite

About The Position

The Senior Clinical Manufacturing Associate supports clinical manufacturing start-up activities and directly performs manufacturing operations for clinical cell therapy. The role calls for enthusiasm, intellectual curiosity, scientific rigor, flexibility, and a strong focus on safety and quality, along with a good understanding of good manufacturing practices. The position involves performing clinical patient-process unit operations, working in a cleanroom and carrying out aseptic processing, and maintaining environmental conditions required for controlled manufacturing areas. The associate references batch records, standard operating procedures, and work instructions to conduct operations, and supports equipment and facility commissioning, production planning, procedure development, and quality-event investigations. The role may also involve related tasks needed to contribute to a new start-up facility. This is an on-site role in Devens, Massachusetts. Available shifts are 6 a.m.–6 p.m. on a rotating schedule that includes weekends and holidays. The associate must be able to work an assigned day, night, weekend, and/or holiday shift and travel to other BMS sites for training and development, typically for a week or less. The work includes physical activity and daily use of personal protective equipment and cleanroom garments.

Requirements

High school diploma and at least 3 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
Experience with GMP compliance, data integrity, and ALCOA+ principles, including direct application.
Ability to work the assigned shift, which may include days, nights, weekends, and/or holidays.
Ability to work in a cleanroom environment and perform aseptic processing.
Comfort working with human blood components.
Ability to work in close proximity to strong magnets.
Ability to travel to other BMS sites for training and development; trips typically last a week or less.
Ability to stand and walk while operating manufacturing or computer equipment for several hours at a time throughout the day.
Ability to carry, lift, push, and/or pull up to 50 pounds several times a day.
Ability to climb, including using stepladders in production areas or stairwells, several times a day.
Ability to bend or kneel several times a day.
Ability to perform overhead reaching while handling production materials, files, or supplies up to 25 pounds several times a day.
Ability to repeatedly move the head and neck, twist at the waist, and use arms, wrists, and hands while performing work tasks.
Ability to wear personal protective equipment and cleanroom garments daily.

Nice To Haves

Bachelor’s degree in a relevant science or engineering discipline is strongly preferred.
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Experience in cell therapy manufacturing, including cell washing, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment.
Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human-derived materials in BSL-2 containment areas.

Responsibilities

Perform clinical patient-process unit operations and support operations described in standard operating procedures and batch records.
Demonstrate practical and theoretical knowledge of the work and use existing solutions to solve simple problems.
Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Identify innovative solutions.
Perform tasks in accordance with safety policies, quality systems, and cGMP requirements.
Complete training assignments to develop necessary technical skills and knowledge.
Work in a cleanroom and perform aseptic processing; maintain manufacturing environmental conditions, including non-viable particulate and viable microbial levels, through area disinfection as required.
Reference batch records, standard operating procedures, and work instructions to complete manufacturing operations.
Assist in setting up manufacturing areas, equipment, and fixtures.
Perform facility and equipment commissioning activities.
Support development of manufacturing operating procedures that are technically sound, efficient, and compliant with cGMP requirements.
Support production planning for daily unit-operation schedules, including people, product, and material flow across multiple shifts.
Support quality-event investigations.
Perform other related tasks as required to contribute to a new start-up facility.