Specialist, Pharma Tech

5+ years

Not Disclosed

Canada

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: BE/BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Technical Lead - Process Development & Commercialization

Main Responsibility:

The primary responsibility of this role is to act as the Technical Lead in the process development and commercialization of new Taro products, as well as to troubleshoot, investigate, and improve current Taro processes and products. The individual will also contribute to problem-solving, process improvement, and technology transfer or validation issues.

Key Duties and Responsibilities:

Process Development and Technical Transfer:
- Lead the conceptual design, process development, and technical transfer for new compounding master formulas.
- Scale-up from an R&D batch size to full commercial production.
- Transfer products from external sites to Taro’s manufacturing sites.
Independent Technical Leadership:
- Serve as the independent technical lead for product launch, transfer, and scale-up projects within operations.
Improvement Projects:
- Lead improvement projects, develop project plans, and establish detailed timelines.
Documentation and Reports:
- Prepare study protocols, reports, SOPs (Standard Operating Procedures), and validation and equipment qualification documents.
Change Management:
- Generate change requests for product introductions, revisions to master formulas, and SOP updates.
- Initiate and manage change controls to support process and product improvements.
Analytical Methodology and Testing:
- Investigate and review analytical testing methodology, interpret results, and provide input on improving test methods.
Manufacturing Process Improvements:
- Investigate and report on potential improvements to existing manufacturing processes.
- Prepare investigational lab batches as required.
Process Reviews and Formula Assessments:
- Conduct process reviews and assess master formula changes for impact on the product and validation status.
Equipment Sourcing and Specifications:
- Assist in identifying and sourcing new equipment.
- Create user specifications, design reviews, and purchase specifications for site improvement activities.
Project Tracking and Reporting:
- Communicate and track projects, generate reports, and liaise with relevant stakeholders to ensure the timely fulfillment of duties and responsibilities.
Non-Conformance Investigations:
- Participate in or lead non-conformance investigations and implement corrective and preventive actions (CAPAs).
Audits and Regulatory Compliance:
- Participate in internal, customer, and regulatory audits as needed.
Customer-Facing Responsibilities:
- Report any adverse events received from customers regarding company products to the pharmacovigilance department/Drug Safety within 1 business day.

Qualifications:

Education:
- Bachelor’s Degree in Chemistry, Pharmacy, Mechanical or Chemical Engineering, or related discipline. Master’s degree or higher is preferred.
Experience:
- Minimum 5 years of experience in a technical role within formulation development, quality, or a compounding environment.
- Exposure to semi-solid dosage forms is preferred.
- cGMP (current Good Manufacturing Practices) experience is required.
Skills:
- Strong organizational, communication, and multi-tasking skills.
- Ability to work effectively in a team environment.
- Basic project management skills.
- Proficiency with computer software for documentation (spreadsheets, word processing).
- Knowledge of statistical software.
- Strong understanding of cGMP and pharmaceutical manufacturing processes.
Problem-Solving:
- Ability to handle non-routine and complex issues such as compounding issues, filling issues, and other related manufacturing problems.

Working Conditions:

The role involves a variety of working conditions, including office and plant environments.
Occasional exposure to chemicals and temperature extremes.
Flexible hours may be required.
Some lifting may be necessary.
Routine tasks may include a mixture of standing, walking, and sitting.

Physical Requirements:

Primarily office-based but with occasional requirements for physical activity in the plant.

This position offers the opportunity to play a key role in the development and commercialization of pharmaceutical products while leading process improvements, addressing technical challenges, and ensuring the smooth transition from R&D to full-scale manufacturing.

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Specialist, Pharma Tech

Job Description

Job Title: Technical Lead - Process Development & Commercialization

Main Responsibility:

Key Duties and Responsibilities:

Qualifications:

Working Conditions:

Physical Requirements:

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