Senior Manufacturing Associate

About the role

The Senior Manufacturing Associate plays a crucial role in DiscGenics' mission to develop and produce IDCT, a cutting-edge therapy for degenerative spine diseases. This role involves executing manufacturing processes in a cleanroom environment, training junior employees, and leading teams to ensure compliance with cGMP standards and regulatory requirements.

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.

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-paced, changing environments.
• 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.
• Able to report to work responsive, free from sedatives, and in a non-sedative state.
• Proficient with Microsoft Office, including Word, Excel, and PowerPoint.

Job Requirements

• Position requires weekend availability.
• Position requires qualified individuals to see, hear, and speak (verbally and audibly).
• 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.
• 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.