Senior Drug Product Technician - Eurofins CDMO Alphora Inc. at Eurofins

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Drug Product Manufacturing, Equipment Operation, Training, Process Technologies, Material Sampling, Packaging, Logbook Review, SOP Drafting, Formulation Trials, API Support, Health and Safety, Team Collaboration, Technical Skills, Pharmaceutical Manufacturing, Quality Assurance

Industry

Medical and Diagnostic Laboratories

Description

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 2024, Eurofins generated total revenues of EUR 6.515 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 The Senior Drug Product Technician position is accountable to the Senior Manager, Drug Product Operations and Engineering. They will be responsible for a variety of Drug Product specific activities related to GMP clinical manufacturing operations including but not limited to, leading GMP production of oral drug products, compression and powder handling equipment operation and compliance with GMP systems within the Drug Product Operations department. In this role they will be hands on and lead all aspects of GMP drug product manufacturing of oral dosage technologies for Phase I and II clinical trials. The individual will become a lead trainer on equipment and processes and ensure skills are transferred to newer technicians. Secondary responsibilities may include working with engineering in equipment training and ordering of Drug Product supplies and warehouse related operations for Drug Product such as material sampling, secondary or clinical packaging and cycle count support. In addition to the primary responsibilities within Drug Product Operations, the they may also provide API plant operational support as needed. DUTIES AND RESPONSIBILITIES: Operate directly and serve as a lead trainer for others on Drug Product specific automated equipment technologies such as rotary tableting, wet and dry granulation, blending of powders, milling, spray drying, encapsulation, and coating. Provide subject matter expertise on equipment operation and processes, and train other technicians so skills are effectively transferred. Execute and lead all aspects of GMP oral drug product manufacturing including but not limited to sampling, compounding, process technologies, and packaging. Support Drug Product warehouse operations including material sampling, production preparation, secondary packaging, and cycle count support. Perform Logbook and batch record reviews pre and post batch, working with QA and formulation team to identify errors and deficiencies. Ensure Cleanroom and facility are in GMP condition and in a state of readiness for batches and client audits/tours. Take the lead in revising and drafting SOP’s, protocols, and batch records as necessary specific to Drug Product Operations. Verify equipment and room cleaning is performed after batches by reviewing logbooks and cleaning requirements. Assist with Operations manager in planning and scheduling equipment for batches. Lead formulation trials and GMP batches with no supervision, working with new technicians and formulators. Support Drug Product engineering personnel with the on-boarding, calibration, maintenance and operation of a wide variety of manufacturing equipment such as tablet presses, fluid bed dyers/coaters, blenders, spray dyer, granulators, etc. Provide API plant operations support as necessary. Comply with cGMP’s in the execution of duties and responsibilities in Drug Product operations. Follow Environmental, Health and Safety rules/regulations and report any workplace injuries or accidents immediately. Adhere to the policies and guidelines set out in the Alphora Employee Handbook. Work harmoniously with all fellow employees. Perform additional duties as required. Qualifications Degree or diploma in a related discipline. 5-10 years of relevant pharmaceutical manufacturing experience. Experience in Drug Product Manufacturing and related technologies is essential. Direct work experience in Pharma GMP knowledge and laboratory environments. Able to perform physically demanding, repetitive tasks for long periods. 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. This posting is supported by AI technology to assist in screening candidates and resumes. NO AGENCIES, CALLS OR EMAILS PLEASE

Responsibilities

The Senior Drug Product Technician will lead GMP production of oral drug products and ensure compliance with GMP systems. They will also train new technicians and support warehouse operations related to Drug Product.