Cell Manufacturing Associate

Planet Pharma; Exton (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player in gene therapy is seeking a dedicated Cell Manufacturing Associate II to join their dynamic team. This role involves critical tasks in the production of sterile cell therapy products, requiring expertise in mammalian cell culture and aseptic processing. You'll thrive in a cleanroom environment, ensuring compliance with industry standards while contributing to groundbreaking therapies. If you are passionate about advancing scientific research and have a background in laboratory practices, this opportunity is perfect for you. Join a collaborative team that values innovation and excellence in the pharmaceutical manufacturing field.

Qualifications

• Minimum 6 months of experience in a relevant field.
• Proficient in aseptic processing and cell biology.
• Knowledge of cGMP and industry standards required.

Responsibilities

• Perform daily production tasks for sterile cell therapy products.
• Maintain aseptic gowning and equipment.
• Document and report inventory tasks and quality items.

Skills

Mammalian cell culture

Aseptic technique

Basic laboratory skills

Verbal and written communication

Interpersonal communication

Education

Bachelor of Science in a scientific discipline

Tools

Microsoft applications

Job description

This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60,000.00/yr - $80,000.00/yr

Direct message the job poster from Planet Pharma

A late-stage, gene therapy company headquartered in Exton, Pennsylvania is looking to hire Cell Manufacturing Associate II to their team. In this role you will be responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.

• Day/Shift: Monday-Friday, 8:00AM-4:30PM

Must have at least 6 months of experience.

• Experience: Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
• 2+ years of experience in mammalian cell culture in an academic or industrial laboratory
• Knowledge of basic laboratory skills (aseptic technique, pipetting, etc.) are required
• Must be comfortable with performing tasks while fully gowned in a cleanroom environment.
• Proficient in Manufacturing Process.
• Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
• Proficient in Mammalian cell biology
• Excellent verbal and written skills
• Good interpersonal communication skills
• Must be willing to work weekends, evenings, and holidays (as needed).
• Responsibilities: Proficient in aseptic processing including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
• Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
• Perform media and reagent preparation duties as required.
• Ability to operate and maintain equipment.
• Perform equipment preventative maintenance, cleaning/disinfection, and basic troubleshooting, as required.
• Perform, record and report various inventory tasks (i.e. consumables, media, cryovial, etc.)
• Ability to train others on support tasks, basic SOPs, equipment, and process operations.
• Achieves PowerUser status on supporting electronic systems (i.e., MasterControl).
• Follows, revises, executes, and authors SOPs and MBRs in accordance with cGMPs.
• Ability to author and review documentation and MBR’s at a high level.
• Ability to author and close quality items, including quality event investigations and deviations.
• Ability to initiate simple change controls and manage tasks required.
• Assists with material procurement and receipt.
• Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
• Manages time well and multi-tasks to complete all assignments and responsibilities with supervisor’s guidance.
• Maintains a safe working environment for self and others, including work area cleanliness.
• Monitors resources and enforces SOPs to ensure data integrity and compliance with industry.
• Participates in process optimization and continuous improvement opportunities.
• Computer Skills: Use of basic Microsoft applications efficiently.
• Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventative Action initiatives, and Change Control procedures.
• Physical Demands:
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands and fingers to handle equipment or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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