Scientist, Product Development

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit:.

Job Summary

Formulation Development - New Products supports all activities required to develop optimise a stable liquid dose formulation to make it suitable for commercial production. The Scientist Formulations Development works under the direction of Senior members of the Formulations Development team to support the development and enhancement of pharmaceutical formulations manufacturing processes and selection of packaging components. This role includes development of liquids dosage forms for ANDA ANDS and 505b2 submissions. The dosage forms include both sterile and non-sterile liquid products not limited to oral Nasal ophthalmic and injectable dosage forms etc.

Job Responsibilities

1. Perform literature search collect relevant scientific information and materials and prepare comprehensive pre-development summaries.
2. Design execute and monitor formulation development experiments using Quality by Design (QbD) principles to develop robust and scalable product compositions.
3. Collaborate with Formulation Development (FD) and Analytical Development (AD) teams to:
• Prepare Reference Listed Drug (RLD) characterization reports
• Define Quality Target Product Profiles (QTPP)
• Identify Critical Quality Attributes (CQAs)
4. Conduct risk assessments as per QbD guidelines and develop Design of Experiments (DoE) for:
• Composition optimization
• Identification of Critical Material Attributes (CMAs)
• Evaluation of Critical Process Parameters (CPPs)
5. Lead the design development and optimization of complex sterile and injectable dosage forms ensuring alignment with regulatory expectations (e.g. FDA ICH guidelines).
6. Compile analyze and interpret stability data collaborate with Analytical Development to identify trends and optimize formulations as required.
7. Apply strong scientific fundamentals and innovative problem-solving approaches to investigate and resolve complex formulation challenges including implementation of unconventional techniques when needed.
8. Develop and implement robust formulation strategies based on QbD and regulatory requirements.
9. Conduct statistically designed experiments (e.g. factorial design) to meet development objectives and ensure process understanding.
10. Author review and manage technical and regulatory documentation including:

• Drug product development sections of dossiers (IND/NDA/ANDA)
• CMC sections
• Technical reports protocols and summaries

1. Collaborate cross-functionally with Technical Services Operations Regulatory Affairs and other stakeholders to ensure successful product development and lifecycle management.
2. Support technology transfer scale-up activities and regulatory submissions including responses to regulatory queries.
3. Perform additional scientific technical or project-related duties as required.

Job Requirements

• Education & Experience
• Bachelors degree (Minimum 5 8 years of experience preferably in a pharmaceutical development environment). Masters degree or PhDin Pharmacy Pharmaceutical Technology science or engineering is preferred.

• Knowledge Skills and Abilities
  • Excellent working and theoretical knowledge of liquid dosage formulations sterile and non-sterile manufacturing combination product requirements.
• 5 years of hands-on experience in respiratory and/or nasal drug delivery. 3 years of hands-on experience in sterile/Injectable pharmaceutical formulation development
• Proven track record of successful formulation development and commercialization.
• Experience with statistical design of experiments (DOE) and data analysis.
• Excellent organization and report writing skills. Advance level of computer skills in Microsoft Office (Word Excel PowerPoint and Outlook).
• Good knowledge of cGMP and regulatory requirements.

At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.

The hiring range for this position is $ 77284.85 - $ 101198.79CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge skills and experience.

We are looking for top talent. If your qualifications differ from those listed above the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization you can excel based on our pay-for-performance philosophy. With comprehensive benefits a pension plan to help you save for retirement and learning and development opportunities we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.

Required Experience:

IC

Employment Type : Full Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 77284 - 101198