At Therapure Biopharma Inc., we’re specialists in biologics. In our two divisions; Therapure Biomanufacturing, and Therapure Innovations, our passion for quality and patient safety underpins everything we do. Therapure Biomanufacturing is a global contract development and manufacturing organization (CDMO); Therapure Innovations is devoted to drug discovery, and research and development. Our scientists are currently developing innovative protein therapeutics in anemia, liver cancer, and hepatitis C.
The incumbent will supervise the Microbiology Laboratory and ensure that all operations are conducted in compliance with cGMP regulations, company policies, safety standards, and departmental procedures and standards. They will plan and supervise the execution of microbiological method development, transfer, optimization, implementation and validation to be consistent with client, production, and regulatory requirements, and assist in planning to maintain adequate resources (adequate pool of trained microbiology personnel, equipment and materials) necessary to efficiently execute microbiology operations.
- Supervise the accurate and timely completion and approval of Microbiology Laboratory testing and records
- Establish Micro trend analysis programs including utility systems and environmental monitoring
- Review and approve, as required, all microbiology test results, validation protocols and reports within assigned timelines
- Review, initiate and approve, as required, changes to assure continuous improvement of microbiology procedures (test methods, training modules, system SOPs)
- Oversee the creation, reviewing, training and implementation of microbiology system SOPs, test methods and training modules
- Assist in creating project plans to meet or establish the microbiology test method transfer/development/validation requirements (timelines/resources) for client manufacturing contracts
- Assist in setting and justifying acceptance criteria for validation studies
- Assist in managing the execution of microbiology method development and optimization for new products
- Troubleshoot methods and equipment as required
- Record and report, according to established procedures, any deviations from company procedures, or other discrepancies that may affect or indicate a microbiological problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long term corrective action including identifying root causes; facilitate and review final implementation of corrective action plans
- Ensure that applicable equipment and analytical instruments in the microbiology laboratory are qualified, maintained and calibrated and that system suitability is properly verified. Review and approve as required Microbiology equipment IQ/OQ/PQ protocols and reports
- Ensure that all Microbiology staff are adequately trained to perform duties prior to performing a function
- Establish schedules for environmental monitoring tests and personnel gowning qualification testing including sampling and microbiological organism identification
- Ensure that the Microbiology laboratory facilities and operations are in compliance with safety and environmental regulations, including chemical and microorganism handling and disposal of laboratory waste
- Act as a back-up to the QC Microbiology Environmental Monitoring Supervisor
- Assist in creating cost analyses for tests
- Assist in establishing and delivering required training programs in aseptic and sterile technique for lab and other personnel
- Research new technology
- Report Health and Safety incidents, accidents or potential hazards
- Coordinate / troubleshoot technical issues to achieve cost effective operations within the Microbiology laboratory
- Performs all other related duties as assigned
TECHNICAL KNOWLEDGE / EXPERIENCE:
- Bachelor’s degree or Microbiology college diploma/certification together with 5-10 years related work experience.
- Demonstrated leadership and management skills.
- Good working knowledge of Global Regulations and cGMPs
- Good leadership skills
- Good working knowledge of aseptic techniques and microbial tests
- Strong technical writing and computer skills
- Good interpersonal and communication skills
- Ability to work independently when needed
- Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
- This position requires vaccination for Hepatitis A and B
- Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shifts
While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources for assistance.
This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.Apply Now