Scientific Leader, Manufacturing Technical Service

APOTEX; Toronto; Hybrid; CAD 96,000 - 134,000; Full time

Benefits offered by this job

Bonus programs

Pension plan

Learning and development opportunities

Disability accommodation

Job summary

Apotex, a Canadian-based global health company, seeks a Scientific Leader in Manufacturing Technical Service to supervise and advance technical support for formulation and process improvements. You will coach teams, run trials, and ensure safe, compliant, and efficient manufacturing across sites.

The role requires a university degree in a related field and at least 10 years’ pharma experience focused on solid dosage forms, scale-up or tech transfer.

Qualifications

• University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
• Minimum 10 years in pharma with experience in solid dosage formulations, scale up or tech transfer.
• Strong English communication, troubleshooting and report writing.
• Knowledge of cGMP, GLP, USP/FDA standards.

Responsibilities

• Supervise technical support projects to improve product formulations and processes.
• Develop and support experimental trials evaluating changes in formulations and materials.
• Monitor full-scale manufacturing and provide technical support and tech transfer as needed.
• Write investigational reports, project updates and recommendations.
• Evaluate data from trials and advise on stability, reprocessing and batch issues.
• Design trials to develop robust manufacturing processes and rework strategies.
• Troubleshoot production challenges and implement corrective actions.
• Train and develop direct reports and ensure compliance with policies.

Skills

Pharmaceutical processes

Process troubleshooting

English communication

Project management

Quality systems knowledge

Education

University degree in Chemistry/Pharmaceuticals

Tools

SAP

MS Office

Job description

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Scientific Leader, Manufacturing Technical Service

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.

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 in order 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 in order to determine the causes and to recommend and implement solutions for improvement.
• Develops, recommends and provides technical support to experimental trials in order to evaluate changes in formulations, raw materials, and manufacturing processes.
• Monitors and supervises the 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 solid 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 their direct reports, which includes, but is not limited to:
  • Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Global Training and Employee Qualification Enterprise Policy.
  • Effectively managing performance for direct reports according to the Global Performance Management Program.
  • Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives.
  • Responsible to ensure compliance of team members (direct reports) with the Global Business Ethics and Compliance Program, Global Quality procedures, Safety and Environment policies, and HR policies.
  • Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
  • Delivers all work in support of our 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 investigation of Quality Notifications and CCFs in SAP (Master Formulae, SAP Recipes and Certificates of Analyses)
  • Thorough understanding and knowledge 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 solid dosage forms, scale up and/or technology transfer.

At Apotex, we are committed to fostering a welcoming andaccessible 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 $ 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.

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