Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support.
This posting reflects an existing vacancy within our organization.
Responsibilities of this role:
- Participate in room cleanings and general maintenance of the GMP and Solid Dosage suites.
- Participate in chemical production activities including: reaction, work-up, purification, crystallization, sieving and packaging.
- Participate in formulation and drug product manufacturing activities including: solid dosage, non-sterile liquid/semi-solids.
- Participate in aseptic processes including: sterile API processing, sterile filtrations, powder/liquid fills and inspections.
- Wash and autoclave equipment and glassware used in GMP production activities.
- Sanitize and maintain API and sterile suites, solid dosage suite and support areas.
- Operate all machinery and equipment involved in chemical synthesis on small and large scale for specific projects.
- Keeps the inventory updated for glassware and equipment. Assists with inventory tracking of raw materials after each batch.
- Operate selected equipment involved in solid dose manufacture.
- Complete aseptic & non-aseptic processes in accordance with current SOPs, worksheets and governing batch records.
- Complete documents in accordance with GMP regulations.
- Maintain logbooks documenting sanitization, equipment maintenance and calibration in accordance with GMP regulations.
- Dispose of waste products in accordance with current SOPs and batch records.
- Coordinates with the research and development group when research products are transferred and/or scaled up to GMP manufacturing.
- Participate in process development.
- Access R&D technology transfer packages and performs documentation drafting including master batch records, protocols, worksheet, SOP’ss etc.
- Prepares documentation such as CCR, deviation report and validation report.
- Shift work may be required.
Qualifications and requirements:
- Post-secondary degree of BSc or higher in a Chemistry, Chemical Engineering or Biochemistry discipline (or equivalent work experience).
- Basic Microbiology knowledge.
- Knowledge of GMP regulations.
- Preferred working experience in a GMP manufacturing environment and/or bulk chemical handling experience.
- Basic math skills.
- Knowledge of chemistry, laboratory skills and operating knowledge of routine chemistry lab equipment and glassware.
- WHMIS training.
- Knowledge of basic office software (i.e. MS Word, Excel, Powerpoint).
- Work in a confined, controlled environment for extended periods of time.
- Read and comprehend detailed instructions to perform job duties.
- Eye hand coordination and manual dexterity essential to operating production equipment.
- Legible writing, effective written and verbal communication.
- Work effectively with others in a team environment.
While we appreciate all applications received, only those selected for an interview will be contacted.
Job Type: Full-time
Pay: $50,000.00-$60,000.00 per year
Benefits:
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Tuition reimbursement
- Vision care
Ability to commute/relocate:
- North York, ON M3J 2S3: reliably commute or plan to relocate before starting work (required)
Experience:
- a Chemistry, Chemical Engineering or Biochemistry discipline: 1 year (required)
Work Location: In person