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.
- 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.
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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