Technologist III, Downstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Technologist III, Downstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Technologist III, Downstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Requisitos
Qualifications
- Bachelor’s degree with 5 years of relevant experience or Master’s 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 $70,000 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 applicant’s experience, knowledge, skills, and abilities.
Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organization’s 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.
Beneficios
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 www.eurofins.ca.
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 www.eurofins.ca
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.
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Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2025, Eurofins generated total revenues of EUR 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.
Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -"API's") as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.
Job Description
We are seeking a highly skilled Technologist Level III - Downstream Manufacturing to join our cGMP Manufacturing team. In this hands‑on 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 operations-including chromatography, TFF, filtration, nanofiltration, and bioconjugation-while also contributing to process transfer, scale‑up, equipment qualification, and documentation. This position is ideal for someone who thrives in a fast‑paced, 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 You'll 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 in‑process 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.
Cross‑Functional 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 hands‑on contributions directly impact the production of cutting‑edge therapeutic products.
⭐ Meaningful, High‑Impact Work
Your daily efforts contribute to the manufacturing of novel biologics with real‑world therapeutic potential.
⭐ Advanced Technology & Skill Development
Operate state‑of‑the‑art purification platforms and gain experience in emerging areas such as bioconjugation and large‑scale TFF.
⭐ Growth in a cGMP Leadership Role
As a Level III Technologist, you'll play a key role in investigations, CQV, and process transfer-perfect 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 well‑being.
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Candidatura gestionada por Eurofins