Scientific Leader - Liquid Manufacturing

Apotex Inc.; Richmond Hill; On-site; CAD 95,594 - 133,832; Full time

Benefits offered by this job

Accommodation for disabilities

Job summary

Apotex Inc. in Canada seeks a seasoned professional to supervise and provide technical support for formulation development, manufacturing processes and technology transfer across sites.

You will work closely with Procurement, Planning, Manufacturing, Quality and R&D to ensure timely restoration to routine manufacture and continuous improvement. As a leader, you will coach Scientific Leaders and Supervisors, maintain high standards of problem solving, and ensure compliant, safe operations with

Qualifications

• University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
• Extensive knowledge of pharmaceutical processes & equipment; strong English communication; good reporting and organizational skills.
• Minimum 10 years in pharma with liquid dosage forms, scale‑up or tech transfer.

Responsibilities

• Investigates formulation and process deficiencies and recommends solutions for improvement.
• Supports experimental trials to evaluate changes in formulations and manufacturing processes.
• Oversees full-scale manufacture to provide technical support and technology transfer.
• Writes investigational reports, project summaries and updates with recommendations.
• Evaluates data from trials and suggests stability batches or corrective actions.
• Designs trials to develop robust manufacturing processes and rework batch failures.
• Troubleshoots production challenges in liquid dosage form manufacturing at all sites.

Skills

Pharmaceutical processes

cGMPs/GLP

Troubleshooting

Project management

SAP

English communication

Report writing

Team leadership

Education

Chemistry/Pharmacy/Pharmaceutical Technology or related

Tools

SAP

Microsoft Office

Job description

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.

Job Summary

Responsible for the supervision of and providing assistance with technical support projects for the improvement of new and current product formulations and processes, launch and demonstration batches, to ensure the manufacture of high-quality products, and the use of efficient manufacturing processes at all Apotex sites. Technical Support Services works closely with Procurement, Planning, Manufacturing, Quality and R&D to ensure that products are restored in a timely manner to routine manufacture in a safe, compliant and efficient state. Technical Support Services also evaluates changes to, or new sources of Active Pharmaceutical Ingredients (APIs) and excipients for use in the manufacture of existing commercial pharmaceutical products.

Coach and support other Scientific Leaders and Supervisors at the site and across sites to maintain a consistent approach to problem solving and continuous improvement of commercial products.

Job Responsibilities

• Investigates formulation and process deficiencies for current products being manufactured to determine causes and recommend and implement solutions for improvement.
• Develops, recommends and provides technical support to experimental trials to evaluate changes in formulations, raw materials, and manufacturing processes.
• Monitors and supervises full‑scale manufacture of products, as required, to provide technical support and/or technology transfer to the manufacturing departments.
• Writes investigational reports, project summaries, project updates, and provides recommendations, as required.
• Screens and evaluates data (e.g., dissolution, assay, and content uniformity) on trials, and makes recommendations for stability batches, reprocessing, rework and batch failures as required.
• Possesses a detailed understanding of the theoretical principles for major manufacturing processes, as applied by the equipment used in the manufacturing process.
• Designs, issues and evaluates trials to develop robust manufacturing processes, and to reprocess or rework batch failures.
• Responsible and accountable for troubleshooting and resolving challenges during the manufacture of pharmaceutical liquid dosage forms at all Apotex sites.
• Anticipates problems and interruptions and develops contingency plans to accurately scope out length of task / project.
• Uses advanced techniques to identify root causes of issues with proposed formulations and processes, and plan a course of action for further investigation and corrective action as required.
• Uses advanced problem‑solving techniques to assess equipment and processes for optimal use, and to arrive at best practices for projects under development.
• Responsible and accountable for decisions made to eliminate problems in Production and to rework or reprocess batch failures.
• Accountable for all changes in deadlines, project deliverables and other areas when making decisions.
• Reviews scientific literature, attends appropriate training, seminars & presentations to maintain expertise in formulation development, manufacturing equipment and processes, raw materials, pharmaceutical technologies, and related areas.
• Provides professional expertise and performs consultations on issues regarding Process Support to other members of Technical Support Services department and other departments.
• Recruits, trains, develops and manages effectively the ongoing performance of direct reports, which includes, but is not limited to:
  • Reviewing and updating development plans for direct reports, ensuring proper training and qualification according to global policies.
  • Effectively managing performance for direct reports according to the global performance management program.
  • Providing regular coaching, feedback and recognition based on expected behaviors, job description and performance on objectives.
  • Ensuring team members comply with business ethics, quality procedures, safety and environmental policies, and HR policies.
• Performs all work in accordance with the Code of Conduct and Business Ethics, and established regulatory, compliance and safety requirements.
• Delivers all work in support of values of collaboration, courage, perseverance, and passion.
• All other duties as assigned.

Job Requirements

• Education
  • University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
• Knowledge, Skills and Abilities
  • Extensive knowledge and experience in pharmaceutical processes & equipment.
  • Strong verbal and written English communication skills.
  • Excellent organization, troubleshooting and report writing skills.
  • Intermediate to advanced level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook).
  • Well‑developed interpersonal and team skills.
  • Multi‑tasking and project management skills.
  • Ability to work independently and make responsible and accountable decisions.
  • Capable of issuing and investigating quality notifications and CCFs in SAP (Master Formulae, SAP Recipes and Certificates of Analyses).
  • Thorough understanding of cGMPs, GLP, SODs, SWPs, USP, BP, EP, SUPAC, FDA and HPFBI.
• Experience
  • Minimum of 10 years of successful working experience in the pharmaceutical industry with related experience in formulations development of liquid dosage forms, scale‑up and/or technology transfer.

Additional Information

We offer accommodation for applicants with disabilities as part of the 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 $95,594.40 - $133,832.16 CAD per year. The final agreed‑upon salary may vary based on factors such as job‑related knowledge, skills and experience.