Senior Scientist, Downstream Drug Development
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.
We are growing! In fact, from 2014 to 2017, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
Oversee all aspects and execute the design, development, scale-up and implementation of protein purification processes from a variety of feed streams. Plan and carry out integrated experimental projects to complete process development objectives. Prepare documents and reports to support pre-clinical, clinical and GMP manufacturing. 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.
Here is what we are looking for:
- Ph.D. 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
- Techniques for reagent, solution and equipment preparation and handling to ensure low endotoxin and bioburden (aseptic technique) at laboratory, development and production scales
- Good written and verbal communication skills
- Work well independently and in a team environment
- Able to keep meticulous laboratory and process records
- DOE (Design of Experiments), process chromatography, diafiltration, filtration, scale-up and development of protein purification methods
- AKTA LC systems, analytical HPLC, gel electrophoresis, spectrophotometry, protein handling and purification techniques
- Preparation of draft and final SOPs, BPRs and other documents for control and recording of GMP processes
Here is what you will be responsible for (but not limited to):
- Lead the transfer-in, development, scale-up and transfer-out of protein purification processes in coordination with other functional groups including cellular & molecular biology (CMB), upstream processing (USP), downstream processing (DSP), and other departments such as Production, Quality Control (QC), Quality Assurance (QA), Validation, and Technical Services, as required.
- Develop, scale and execute protein purification processes, from 100 L scale under appropriate conditions (development to manufacturing scale, aseptic, non-GMP, GMP grades).
- Supervise the DSP group on day-to-day project and non-project related activities.
- Plan and conduct protein purification research and development experiments using established and new protocols.
- Provide scientific and technical oversight on assigned projects.
- Recommend and implement processes and procedures, and communicate appropriately with Clients and internal project teams.
- Prepare project proposals, SOWs, work plans, protocols, records and reports, including general templates for use across multiple projects, and maintain project-related records and trackers.
- Complete 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 BPRs, and execute documents at the appropriate level of compliance for non-GMP and GMP projects.
- Analyze and characterize process intermediates and protein products using a range of bioanalytical techniques.
- Evaluate new equipment and techniques, and provide recommendation for change and/or purchase.
- Work on multiple projects both independently and as part of a team.
- Regularly review and provide analyses on related competitive technology and products and potential impact on project.
- Prepare documentation in support of CMC sections for INDs.
Interested candidates can send their resume and cover letter to email@example.com. Please reference Senior Scientist, DSP in the subject line. 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 at HR@therapurebio.com for assistance.