Manufacturing Associate II

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The Biotherapeutics Manufacturing Centre (BMC) is a Contract Research, Development and Manufacturing Organization that is based at the Ottawa Hospital Research Institute. Working as part of a multidisciplinary team, the Manufacturing Associate Level II is responsible for the GMP (Good Manufacturing Practice) regulated manufacturing of sterile clinical biological products. The successful candidate will carry out processes detailed in production records by performing technical tasks, including aseptic operations and operating production equipment in a GMP environment. They will carry out pre- and post-manufacturing tasks to ensure seamless transition between product runs, including facility cleaning, maintenance, and on-boarding of equipment as well as keeping records according to Good Documentation Practices (GDP) standards. The successful candidate may also be required to coordinate with clinical teams for OHRI-sponsored clinical trials where the investigational product is being manufactured at the BMC.

Major Responsibilities Include:

• Actively participate in manufacturing campaigns of sterile clinical biological products.
• Record, report and investigate non-conformances in collaboration with the Quality Assurance (QA) department.
• Draft and review standard operating procedures (SOP), batch production records and other controlled documents related to GMP manufacturing.
• Support sourcing and ordering of materials and tracking of inventory for production.
• Participate in the development of new processes and assays by executing experiments in collaboration with the R&D laboratory.
• Evaluate processes and identify areas of improvements to optimize processes and regulatory requirements.
• Support the development of new methods and technologies to enhance operations.
• Plan and coordinate manufacturing operations, including participation in GMP shifts, cleaning shifts, other such task planning in conjunction with team members

Basic Requirements (Education/Experience):

• Minimum 3-year diploma from a technical college in Biotechnology or related field, or 3-year undergraduate degree in Life Sciences, Biotechnology, Biochemistry, Molecular/Cell Biology or related field
• 5+ years relevant work experience in biomanufacturing
• Demonstrable experience executing biologic operations in a controlled, GMP-compliant environment; experience with Grade C or higher preferred
• Experience performing mammalian cell culture under aseptic conditions
• Experience drafting and reviewing technical standard operating procedures (SOP) and batch production records (BPR)
• Experience working with specialized biomanufacturing equipment and process workflows

Preferred Qualifications:

• Experience performing human cell culture procedures in compliance with regulatory standards
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Version 2 (TCPS2) and Good Clinical Practice (GCP) certifications
• Experience executing of operations within an isolator
• Experience working with bioreactors
• Experience working with tangential flow filtration and chromatography

Contract Details:

This is a full-time contract.

Salary: Min: $34.176/hr - Max: $45.567/hr

Comments to Applicant:

Please send as a SINGLE PDF your cover letter, complete CV with description of research experience, and contact information. Applicants must refer to "Manufacturing Associate II" in the email subject line. We encourage all qualified persons to apply.

Contact Info:

Name: Dr. Jennifer Quizi

Title: Director, Scientific Operations

Program: Biotherapeutics Manufacturing Centre

Ottawa Hospital Research Institute

Address: 501 Smyth Road, Ottawa, ON K1H 8L6

Email:

Website:

The Ottawa Hospital Research Institute is committed to building and sustaining a welcoming and supportive culture that promotes equity, diversity and inclusion for trainees, researchers, and staff. We are devoted to identifying and removing barriers that limit equitable access to opportunities within our organization. The Ottawa Hospital Research Institute strongly supports initiatives that encourage the participation of all groups, in particular the four groups defined in the Employment Equity Act (women, Indigenous peoples, persons with disabilities and members of visible minorities).

We thank all applicants for their interest. However, only those invited for an interview will be contacted. The Ottawa Hospital Research Institute is an equal-opportunity employer. Upon request, accommodations due to a disability are available throughout the selection process.