Gmp Manufacturing Specialist

2 weeks ago

Edmonton, Canada University of Alberta Full time

**MED Surgery**:

- Competition No.

**S100351024**
- Posting Date

**May 05, 2023**
- Closing Date

**May 12, 2023**
- Position Type

**Full Time - Grant Funded**
- Salary Range

**$51,055 to $69,342 per year**
- Grade

**08**
- Hours

**35**

This position is a part of the Non-Academic Staff Association (NASA).

This position has a term length of 1 year plus a day and offers a comprehensive benefits package which can be viewed on our Benefits Overview page.

**Location**

Work will primarily take place at North Campus Edmonton.

**Working for the University of Alberta
The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community.

The University of Alberta is teeming with change makers, community builders, and world shapers who lead with purpose each and every day. We are home to more than 40,000 students in 200+ undergraduate and 500+ graduate programs, over 13,000 faculty and staff, 260,000 alumni worldwide and have been recognized as one of Canada’s Greenest Employers for over a decade.

Your work will have a meaningful influence on a fascinating cross section of people—from our students and stakeholders, to our renowned researchers and innovators who are quite literally curing diseases, making discoveries and generating solutions that make the world healthier, safer, stronger, and more just.

**Working for the Department/Faculty**

**Position**

Alberta Cell Therapy Manufacturing (ACTM) manufactures a variety of cell therapy and vaccine products for clinical trials in compliance with national and international standards. These products are utilized in human clinical trials. Health Canada requires this manufacturing to be carried out under a high degree quality assurance and quality control - Good Manufacturing Practices (GMP), impeccable record-keeping, strict training and standardized procedures. ACTM’s provides these services on a fee-for-service basis with clients across Canada and potentially international clients as well.

The position is responsible for manufacturing cell therapy products in compliance with Good

Manufacturing Practice (GMP) for use in human clinical trials, translation of experimental cell production

methods to GMP compliant protocols, and equipment and cleanroom operation and maintenance. This position may also participate in Aseptic Fill Finish Activities in compliance with Good Manufacturing Practice. Aseptic Fill Finish is the process of filling vials with drug product that will be injected into patients.

**Duties**

GMP manufacture of cell formulations for clinical trials and fill finish activities:

- GMP production of cell therapy products from the receipt of starting materials through to delivery of the product to the clinical site including Quality Control testing.
- Performs aseptic fill finish activities as required
- Work in a compliant manner in the cleanroom facility including wearing proper cleanroom attire, moving materials into the cleanroom according to documented procedures and assessing environmental monitoring parameters.
- Regulatory Medical Screening required
- Ensure that the manufacturing process for both cell therapy and fill finish is performed in compliance with approved SOPs and GMP requirements.
- Document production operations in corresponding batch records according to established procedures.
- Write and execute specifications, deviation investigation reports, change controls, Corrective, and Preventative Actions (CAPAs).
- Participate in in-house, client and regulatory audits as required.

Translation of experimental cell production methods to GMP-compliant protocols:

- Contribute to the development of cell production methods for GMP production using appropriate production equipment and raw materials.
- Contribute to protocol/batch record development.
- Assist in sourcing materials and qualifying equipment to translate experimental cell production methods into the cleanroom to ensure GMP compliance.
- Support of the GMP Development Lead to ensure development timelines are met.

GMP Manufacturing Specialist responsibilities:

- Mentor junior staff and cell processing specialists in the cleanroom setting. Fills a lead hand supervision role.
- Supervision of staff performing equipment cleaning and environmental monitoring to meet GMP requirements in the ACTM facility. (includes review of EM data generated.)
- Determine when situations may result in deviation from approved procedures and notify management as needed.
- Assist with the review and release of controlled materials used in GMP manufacturing.
- Assist with review of GMP documents such as technical reviews of SOPS, controlled forms and batch records used in manufacturing.
- Assist with writing and revision of GMP batch records.
- Assist the GMP Production Lead with manufacturing schedule and

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