Technologist III, Downstream Manufacturing Biologics Eurofins CDMO Alphora, Inc.

We are seeking a highly skilled Technologist Level III Downstream Manufacturing to join our cGMP Manufacturing this handson and technically focused role you will play a pivotal part in producing novel biologics and therapeutics while ensuring full compliance with cGMP standards.

You will support and execute downstream operationsincluding chromatography TFF filtration nanofiltration and bioconjugationwhile also contributing to process transfer scaleup equipment qualification and documentation. This position is ideal for someone who thrives in a fastpaced regulated environment and enjoys combining technical depth with operational excellence.

 The Technologist III - Downstream Manufacturing is responsible for playing a crucial role in the cGMP manufacturing of novel biologics and therapeutics as well as ensuring cGMP compliance of all manufacturing areas. The successful candidate will support manufacturing activities that involve downstream processing steps including chromatography tangential flow filtration (TFF) filtration and nanofiltration as well as bioconjugation.  The ideal candidate will also play key roles in the preparation of cGMP documentation such as batch records and CQV protocols in addition to aiding activities such as process transfer and scale up as needed. 

At Eurofins CDMO Alphora Inc. our mission is to harness the power of biotechnology and bioprocessing to create innovative complex medicines that will improve the lives of patients worldwide. With a dedicated team of experienced scientists motivated technologists and state-of-the-art process development (PD) facility we are thrilled to be at the forefront of the biopharmaceutical CDMO industry in Canada. Join us on this exciting journey as we push the boundaries of scientific research and provide hope to our most vulnerable.

What Youll Do

As a Technologist III you will be a key technical contributor and manufacturing leader supporting downstream cGMP operations:

Downstream Processing & Execution

• Serve as a primary technical contact for transferring processes from Process Development (PD) into cGMP manufacturing.
• Operate advanced purification equipment including AKTA Ready Gradient AKTA Ready Gradient XL AKTA Readyflux and AKTA Readyflux XL.
• Execute downstream processing steps such as chromatography TFF depth filtration nanofiltration viral inactivation and protein bioconjugation.
• Perform inprocess sampling and basic analytical tests within the manufacturing suite.

Quality Compliance & Documentation

• Assist in technical investigations perform Root Cause Analysis (RCA) and prepare thorough deviation reports and CAPA plans.
• Write and review batch records SOPs and cGMP documentation.
• Author and execute commissioning qualification and validation (CQV) protocols.
• Ensure facility and equipment logbooks are completed accurately and in compliance with SOPs.
• Maintain a constant state of inspection readiness for internal audits client visits and regulatory inspections; serve as an SME when required.

CrossFunctional Collaboration

• Work closely with Upstream Processing QA and QC to coordinate smooth material handoffs and timely sample testing.
• Partner with QC Raw Materials on material release and inventory management.
• Order consumables raw materials and equipment; coordinate preventive maintenance and equipment calibration.

Operational Excellence & Safety

• Support suite cleaning room changeovers and overall GMP cleanliness according to CL2 and cGMP expectations.
• Ensure junior staff follow PPE requirements and exhibit proper ergonomic practices especially when handling biohazardous materials or heavy equipment.
• Promote a culture of safety quality and continuous improvement on the manufacturing floor.

Why Work Here

Join a team where your technical expertise and handson contributions directly impact the production of cuttingedge therapeutic products.

Meaningful HighImpact Work

Your daily efforts contribute to the manufacturing of novel biologics with realworld therapeutic potential.

Advanced Technology & Skill Development

Operate stateoftheart purification platforms and gain experience in emerging areas such as bioconjugation and largescale TFF.

Growth in a cGMP Leadership Role

As a Level III Technologist youll play a key role in investigations CQV and process transferperfect for advancing toward senior manufacturing or technical leadership positions.

Collaborative Supportive Environment

Work with upstream quality development and engineering teams that share a commitment to excellence and innovation.

A Culture of Quality & Safety

Thrive in an environment that values accuracy compliance operational efficiency and employee wellbeing.

Qualifications :

• Bachelors degree with 5 years of relevant experience or Masters degree with 3 years of relevant experience or an acceptable combination of other academic qualifications and experience.
• Strong theoretical and practical understanding of aseptic techniques.
• Strong understanding of Current Good Manufacturing Practices (cGMP) in FDA Health Canada and ICH guidelines in biomanufacturing.
• Working knowledge of protein chemistry and protein purification.
• Working knowledge and experience with performing commissioning qualification and validation activities.
• A strong understanding of core downstream process techniques that include chromatography TFF and filtration. Knowledge of and experience with bioconjugation is an asset.
• Familiarity with Cytiva UNICORN software.
• The ability to effectively support the execution of multiple client projects while respecting the unique nature of every client project. 
• Strong interpersonal skills and ability to work collaboratively as a member of a cross-functional team.
• Excellent communication GMP documentation and organizational skills.
• Strong problem-solving skills.

The starting annual base compensation for this position is $70000 CAD. The actual offer reflecting the total compensation package plus benefits will be determined by a number of factors which include but are not limited to the applicants experience knowledge skills and abilities.

Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organizations compensation and may represent estimated ranges provided by third-party job boards. The organization offers competitive wages and a comprehensive total rewards package which will be discussed during the interview process.

At Eurofins CDMO Alphora we leverage artificial intelligence (AI) technology to support our recruitment process including preliminary screening of applications and resumes. All hiring decisions are made by human reviewers.

This posting is for a current vacancy and the successful candidate will start as soon as possible.

Additional Information :

At Eurofins we offer excellent full-time benefits including health & dental coverage life and disability insurance RRSP with 3% company match paid holidays paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may e-mail a request via the website at .

As a Eurofins employee you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins please explore our website at 

We thank all applicants within commuting distance of GTA Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

NO AGENCIES CALLS OR EMAILS PLEASE

Remote Work :

No

Employment Type :

Full-time