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Ccrm Operations Associate Ii

8 hours ago

Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
**Position Summary**:
As an Operations Associate II at CCRM, you will be part of a diverse bioengineering team focused on designing and implementing good manufacturing practices (GMP) production projects for CCRM’s GMP facility. You will provide technical expertise and will work with the team to define and execute project tasks. You will be an operations leader in bringing new and innovative products to the market to enable life-saving advances in cell and gene therapy and regenerative medicine.

**Responsibilities**:

- This position will have responsibilities in CCRM’s GMP facilities.
- Extract information from equipment manuals and other source documents and write user-friendly standard operating procedures (SOPs) that describe the equipment, key operating parameters, maintenance, and cleaning procedures.
- Develop, revise, and review SOPs, qualification/validation protocols and reports
- Support building & establishing the manufacturing team by participating in the onboarding and training processes of new colleagues.
- Support the development and execution of appropriate Safety, Training, Gowning, Material Movement, Cleaning, and Scheduling.
- Responsible for maintaining equipment in good working order including compliance to the calibration, preventive maintenance, and requalification requirements.
- Train end-users on equipment operation, maintenance, and other quality procedures.
- Execute production batch records or other high-quality documents (i.e., HVAC validation) that meet applicable GMP standards and are appropriate for the intended audience.
- Responsible for cleaning and maintaining in state of control in classified manufacturing areas. Write and update standard operating procedures and master batch records.
- Follow Batch Records (BRs), SOP Logbooks, Forms, as of GMP part of manufacturing activities
- Adhere to cGMPs and GDP (good documentation practices).
- Operate pilot-scale bioprocessing and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance and Logistics counterparts.
- Collaborate with the Process Development and Manufacturing Sciences and Technology group to transfer new projects into GMP
- Assist in the training of employees in aseptic processing.
- Implement a program to monitor and control operations from an employee safety perspective.
- Other process related tasks that may arise.

**Qualifications**:

- Bachelor’s degree in science (Biological or Life Sciences, Biotechnology or Microbiology preferred); Master’s preferred.
- 3+ years of experience in biopharmaceutical based GMP manufacturing operations/Cell Therapy/Upstream or Downstream Bioprocessing.
- Solid knowledge of GMP regulations.
- Strong English written and verbal communication skills.
- Proven track record of writing GMP documents (i.e., SOPs, validation procedures).

**Desired Characteristics**:

- Proven track record of working in Grade A and B controlled environments performing aseptic processing.
- Proved track record of working in upstream single use bioreactor operations. and/or in downstream process
- Solid understanding of Health Canada/Food and Drug Administration GMP regulations and Quality Assurance principles.
- Technical understanding of upstream and/or downstream processes
- Excellent aseptic/sterile techniques
- Ability to deliver high quality product and other deliverables, paying attention to details.
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
- Understanding of local Health and Safety regulations.
- Excellent communication and interpersonal skills with assertive, responsible, and accountable attitude.
- Strong working knowledge of Microsoft Office.
- Basic familiarity with enterprise quality management software.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

CCRM is committed to accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.