Job purpose

The main responsibility of this position is to act as the technical lead in the process development and commercialization of new Taro products and to design, investigate, improve, or trouble shoot current Taro 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.

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.
• Responsible for MES MBR and PMBAR creation and review
• Act as an independent technical lead for product launch, transfer, scale-up and alternate vendor 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.
• Initiate and manage change requests related to product introductions, SAP setup (Item numbers, Quality Instructions, BPMs, etc.), master formula revisions, process improvements, and SOP updates.
• 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.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

Knowledge, Skills and Abilities:

• 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.

Background and Experience:

• 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 7 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.

Problem Solving:

• Non-routine and complex problems: compounding issues, filling issues and other related problems

Working conditions

Wide variety of working conditions including all areas of the office and plant. Occasional exposure to chemicals and higher or lower than normal temperatures. On occasion flexible hours of work may be required. Some lifting may be required. Routinely a mixture of standing/walking/sitting are required.

Physical requirements

Office based

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $71,500 to $89,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).