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Senior MS&T Engineer

4 months ago

Salt Lake City, United States DISCGENICS INC Full time
Job DescriptionJob Description

DiscGenics is a privately held, clinical biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine.

Summary:

The Manufacturing, Science, and Technology (MS&T) group is responsible for scale-up and ongoing technical support of manufacturing processes for a revolutionary cell therapy. This position will be involved with both upstream and downstream processes using aseptic processing techniques in a cleanroom environment.

The candidate must be proficient in equipment commissioning, standard operating procedures, batch records, change control, investigations, and data analysis. The role may also involve product development activities as the company grows and expands. Experience in commercial cGMP manufacturing (biologics, pharmaceuticals, medical device) is highly preferred.

This role interacts with all departments and all levels of the organization in a collaborative and positive way.

Essential Duties and Responsibilities:

  • Draft, execute, and summarize equipment commissioning and qualification documents (URS, FRS, System Risk Assessment, Design Review, Design Qualification, IOPQ).
  • Draft standard operating procedures (SOPs) for the cell therapy manufacturing process.
  • Draft, review, and update commercial batch records.
  • Generate engineering drawings, technical reports, specifications, and other supporting documentation as needed.
  • Communicate data and findings in engineering and cross-functional team meetings.
  • Coordinate with outside vendors, contract labs, and equipment manufacturers.
  • Scale-up of the pilot process to a full commercial scale. Serve as a technical expert to receive the technology transfer from Development to cGMP manufacturing.
  • Packaging-related responsibilities including carton design, packaging, and shipping studies.
  • Execution of aseptic process validation / media fills.
  • Process performance qualification (PPQ) of upstream and downstream processes.
  • Manage production runs and events in cGMP manufacturing environment.
  • Use previous experience and understanding to resolve a wide range of challenges and tasks.
  • Operate with minimal oversight and guidance on new projects or assignments.
  • Other duties as assigned.

Job Requirements:

  • Excellent written and verbal communication skills with expertise in good documentation practices.
  • Demonstrated ability for independent work, thought, and analysis.
  • Established knowledge of biologic processes and aseptic technique (preferred).
  • 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 365, including Teams, Word, Excel, and PowerPoint.

Education and Experience:

  • B.S. in bio, chemical, mechanical, packaging, or manufacturing engineering (or related discipline).
  • Minimum 5 years of relevant cGMP experience in commercial biologics, pharmaceutical, or medical device production environment.
  • Relevant experience with both upstream and downstream processes.
  • Advanced statistical analysis skills preferred.
  • Working understanding of cGMP, 21 CFR Part 11 and design control regulations preferred.

Working Conditions:

Position requires qualified individuals to see, hear, and speak English (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 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.