Manufacturing Associate

Company Information Castle Creek Biosciences is a late-stage biotechnology company developing re-dosable cell and gene therapies. It is conducting a pivotal Phase 3 clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Castle Creek, a Paragon Biosciences portfolio company, is headquartered in Exton, Pennsylvania with additional office space in Chicago, Illinois. Learn more at castlecreekbio.com.

Role Summary 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.

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.

Education

• Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)

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).