Senior Manufacturing Associate
DISCGENICS INC
Summary
As DiscGenics prepares to commercialize IDCT, the Senior Manufacturing Associate will be a critical role in executing the daily functions of making IDCT from engineering through commercial production.
Job description
This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.
Essential Duties and Responsibilities
- Execute cell culture manufacturing processes, within a cleanroom environment, with minimal supervision.
- Execute aseptic manufacturing processes within a biological safety cabinet.
- Train junior employees in all aspects of cGMP manufacturing.
- Ability to step in and lead a team when supervisor is not present.
- Ability to troubleshoot mechanical and process issues.
- Maintain production records to comply with cGMP and regulatory requirements.
- Participate in the development and execution of validation protocols, equipment IOQ/PQ, and SOP creation.
- Other duties as assigned
Job Requirements
- Bachelor's degree in related field with 6 years relevant experience or high school diploma with 9 years of relevant experience.
- Proficient with computers and administrative software.
- Flexible team player, able to adapt to fast pace, changing environment
- Exceptional time management and multi-tasking skills.
- Team leadership skills and team player.
- Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
- Regular and predictable attendance.
- Ability to report to work responsive, free from sedatives, and in a non-sedative state.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
Working Conditions
Position requires weekend availability.
Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.
Must be able to lift and carry up to 50 pounds. This position is in the production plant, employees must be able to stand on their feet between 7-9 hours daily, while wearing cleaning room attire which includes mask and gloves.
Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.
Must be able to work unimpaired.
Weekend and shift work may be required in the future.
Requirements
- Bachelor's degree in related field with 6 years relevant experience or high school diploma with 9 years of relevant experience.
- Proficient with computers and administrative software.
- Flexible team player, able to adapt to fast pace, changing environment
- Exceptional time management and multi-tasking skills.
- Team leadership skills and team player.
- Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
- Regular and predictable attendance.
- Ability to report to work responsive, free from sedatives, and in a non-sedative state.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
Company overview
DiscGenics Inc. is a privately held, clinical-stage biotechnology company headquartered in Salt Lake City, Utah, focused on developing innovative regenerative cell-based therapies for degenerative diseases of the spine. Founded in 2007, the company specializes in creating allogeneic cell therapies derived from intervertebral disc cells to address chronic back pain, a condition affecting millions worldwide. DiscGenics' lead product candidate, IDCT (rebonuputemcel), is an injectable disc cell therapy that utilizes proprietary Discogenic Cells to treat mild to moderate degenerative disc disease. The company has raised over $71 million in funding, including a $50 million Series C round in 2020, and is conducting concurrent clinical trials in both the United States and Japan. With a team of 11-50 employees, DiscGenics operates a state-of-the-art manufacturing facility in Utah and has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for IDCT, positioning it as a pioneer in non-surgical, potentially regenerative solutions for spinal disorders.