Therapure Biopharma Inc. (TBI) is an integrated biopharmaceutical company that provides contract manufacturing services to clients for the development, manufacture, purification, and packaging of therapeutic proteins.
The incumbent will oversee all aspects, and execute the design, development, and implementation of laboratory work related to bioprocessing and bioanalysis, principally in the areas of protein production, purification and analysis. Plan laboratory work in a standard R&D laboratory setting in support of CDMO and internal projects. Supervise and lead experimental projects in small teams as required. Prepare/approve documents and reports of work completed. Monitor, recommend and incorporate state-of-the-art and industry-leading technologies and practices. All activities are conducted at a high level of independence and accountability, with appropriate interaction with other departments.
- Lead the transfer-in, development, qualification, validation of analytical methods in coordination with other departments such as Quality Control (QC), Quality Assurance (QA), as required.
- Work on multiple projects both independently and as part of a team.
- Recommend and implement processes and procedures, and communicate appropriately with Clients and internal project teams.
- Prepare project proposals, work plans, protocols, records and reports, including general templates for use across multiple projects, and maintain project-related records and trackers.
- Plan and conduct protein purification research and development analyses using established and new protocols.
- Provide scientific and technical oversight on assigned projects.
- Analyze and characterize process intermediates and protein products using a range of bioanalytical techniques.
- Supervise the Analytical Development group on day-to-day project and non-project related activities.
- Prepare written reports of results, analyses, scientific interpretations and summaries of experimental work.
- Present results, recommendations and future plans.
- Draft and finalize laboratory methods and procedures, SOPs and execute documents at the appropriate level of compliance for non-GMP and GMP projects.
- Evaluate new equipment and analytical methods, and provide recommendation for change and/or purchase.
- Regularly review and provide analyses on related competitive technology and products and potential impact on project.
- Perform all other related tasks as assigned.
- PHD. or M.Sc. with 3-5 years’ industry experience in protein purification, chemistry, protein chemistry and analysis
- Hands-on experience in development and execution of protein purification/expression and analysis techniques
- 3-5 year of Supervisory experience in leading a Team
- Good written and verbal communication skills
- Work well independently and in a team environment
- Able to keep meticulous laboratory and process records
- Demonstrated ability to lead the planning and execution of research and development analyses and projects
- GMP, GDP compliant product preparation, analytical methods and record keeping
TECHNICAL KNOWLEDGE / EXPERIENCE:
- Experience in R&D and Quality Lab environments
- Knowledge of compendial test requirements, US and Europe Pharmacopeia
- Experience in transfer, verification and validation of analytical methods used for in-process, release and stability testing of biopharmaceutical products
- Experience writing experimental and GMP documents in accordance with departmental and company Quality Standards
- Knowledge and practical experience in protein analysis such as BCA, Western Blot, SDS-PAGE, ELISA, Potency and Functionality Cell Based assays, SEC-HPLC and concentration analysis using UV-Vis Spectrophotometer
- Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs.
- This position requires vaccination for Hepatitis A and B
- 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