What are the responsibilities and job description for the Manufacturing Associate position at Paragon Biosciences LLC?
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).
