Specialist, Pharmaceutical Technology

What Our Client Offers:    

• A safe and clean; GMP regulated work environment
• Opportunities for career growth and development
• A competitive wage/salary
• Incentive bonus programs that are designed to reward employees for their individual contributions
• Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
• Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

Our Brampton client is presently looking for a Specialist, Pharmaceutical Technology to join their team.

The main responsibility of this position is to act as the technical lead in the process development and commercialization of new products and to design, investigate, improve, or trouble shoot current processes and products.  The individual will also participate in problem solving, process improvement, and other general issues that may arise in a technology transfer or validation.

Principal Duties and Responsibilities :

• Responsible for the conceptual design, process development, and technical transfer of new compounding master formulas which include scale-up from an R&D batch size to full commercial size and transfer of products from external sites.
• Act as an independent technical lead for product launch, transfer and scale-up projects within operations.
• Lead improvement projects and provide project plans and detailed timelines where needed.
• Prepare study protocols and reports, SOPs, validation and equipment qualification documents.
• Generate change requests for product introductions, master formula revisions, improvement initiatives and SOPs.
• As requested, investigate and review analytical testing methodology, interpret results and provide input to improve existing analytical test methods.
• Investigate and report on possible improvements to existing manufacturing processes and prepare investigational lab batches, as required.
• Conduct Process Reviews and assess master formula changes for impact to product and validation status.
• Assist in identification and sourcing of new equipment, create user specifications, design reviews and purchase specifications to support process and site improvement activities.
• Communicate, generate reports, liaison and track projects to fulfill the above principle duties and responsibilities.
• Participate in and/or lead Non Conformance Investigations.
• Complete Corrective and Preventive Actions (CAPA’s).
• Initiate and follow through with actions required to close Change Controls.
• Participate, as required in Internal, Customer and Regulatory Audits.
• Good organizational skills and multi-tasking ability.
• Strong communication skills (written and verbal) and proved ability to work effectively in a team environment.
• Basic project management skills.
• Good computer skills are needed for documentation work, which includes writing of SOPs and technical reports. Working experience with computer spreadsheets and word processing is required.
• Knowledge of statistical software.
• Good knowledge and understanding of current Good Manufacturing Practices (cGMP).
• Experience in a pharmaceutical environment with c-GMP knowledge is preferred.

Knowledge, Skills and Abilities

• Minimum Bachelor’s Degree in a Chemistry, Pharmacy, Mechanical or Chemical Engineering or related discipline. Candidates possessing Master’s or higher level degrees are preferred.
• Minimum 5 years of related experience specifically in a technical role within formulation development, quality or compounding environment.
• Experience in a pharmaceutical environment with c-GMP knowledge with exposure to semi-solid dosage forms is preferred.
• Good understanding of test methods, data interpretation and inference

***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections