Eurofins CDMO Alphora is looking for Drug Product Technicians to join our dynamic and growing team!
Our organization is growing! We offer both entry level roles as well as roles for more senior candidates with relevant experience, to join our expanding drug product development operations.
WHO ARE WE?
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 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.
At senior level 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, they may also provide API plant operational support as needed.
DUTIES AND RESPONSIBILITIES:
- Operate directly 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 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.
- 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.
- Support formulation trials and GMP batches, working with new technicians and formulators.
- Opportunity to 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.
- Comply with cGMP's in the execution of duties and responsibilities in Drug Product operations.
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.
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.
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.
