Clinical Manufacturing Associate

Job Description

Job Summary:

• Manufacture human blood derived cell therapies per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment of a multi-product clinical facility under the supervision of Manufacturing Management.
• Clinical Manufacturing Associates adhere to regulatory requirements while performing job functions.
• Job duties are performed within a team environment according to an assigned schedule.
• Communication of production deviations and assistance with quality investigations are required, as applicable.
• This position is a member of the Cell Therapy Development and Operations (CTDO) organization.

Duties and responsibilities:

• Production of human cell therapy lots through cell culture, harvest, and cryopreservation.
• Perform operations utilizing Aseptic technique.
• Become fully trained and qualified in all aspects of assigned processes.
• Develop a high level of technical knowledge of project(s).
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time, internal production logistics.
• Record production data and information in a clear, concise, format according to proper GDPs.
• Work in a team based, cross-functional environment to complete production tasks required by schedule.
• Assist tech transfers in and out of the clinical facility.
• Motivated, team consciousness individuals are needed to fulfill job requirements.
• No direct reports will be assigned to this job role.
• Perform other tasks as assigned.

Education, Experience and Skills:

• Associates or Bachelors degree in related field is preferred
• Minimum of high school diploma and/or equivalent combination of education and experience is required
• 2-5 years of relevant GMP manufacturing experience.
• On the floor experience which demonstrates proficiency and compliant schedule adherence is highly desired.
• Extensive knowledge of SOPs and cGMPs and the knowhow to work within a regulatory environment.
• Demonstrates aptitude for engineering principles and manufacturing systems.
• Adaptable to a fast paced, complex and ever-changing business environment

Knowledge, Skills, and Abilities:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• General knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices within industry.
• Sufficient vision and hearing capability to work in job environment.

Working conditions:

• Must have the ability and flexibility to work assigned shift (Day, Night, Weekends and/or Holidays).
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily.
• This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
• Must be able to work in a cleanroom environment and perform aseptic processing; 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.
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Must be comfortable being exposed to human blood components.
• Must be able to be near strong magnets.

Physical Requirements:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
• During higher times of processing these activities may increase.
• 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).
• Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
• Stand and Walk – Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
• Carrying weight, Pushing, Pulling Lifting – Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Climb – Required to climb (use of stepladders in production areas, or stairwells) several times a day.
• Bend and Kneel – Required to bend or kneel several times a day.
• Overhead work – Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
• Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
• Twisting – Required movement of twisting waist while setting up equipment several times a day, throughout the day.
• Repetitive Use – Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
• Due to the nature of clinical cell therapy manufacturing, mandatory overtime may be required.