Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
The Scientific Leader, Technical Operations (CI) RD9 will be primarily responsible for:
- Leading a portfolio of Continuous Improvement projects: Technical Operations is primarily involved in product life cycle management (PLCM) post launch of a product. This includes Continuous Improvement encompassing optimization or re-engineering of the manufacturing processes to proactively improve process performance or to mitigate risk of failure.
- Knowledge of Technology Transfer of New Products according to predefined process to ensure that they are ready for validation and successful commercial manufacturing.
- Providing technical support to products that are subject to API or critical Raw Material changes post regulatory approval, where applicable
- Demonstrates an expert level of operational knowledge of solid dose products and their manufacturing processes to add value to investigations, evaluations and recommendations. Is able to mentor more junior staff as they develop their skills and knowledge.
- Demonstrates and applies an expert level of knowledge of Production equipment. Reviews and proposes changes to SODs based on expert knowledge of equipment capabilities and operation.
- Demonstrates a thorough understanding of regulatory guidance requirements and discusses them with Regulatory Affairs. Accurately incorporates regulatory requirements governing proposed changes into written documents. Briefs stakeholders and senior management on the implications of regulatory requirements on projects and their timelines.
- Collects and appropriately formats data. Utilizes advanced statistical tools for analyzing process data from investigational trials, commercial manufacturing batches and Design of Experiments.
- Understands and interprets standard and non-standard laboratory test results. Proposes appropriate non-standard testing in order to progress investigations and evaluations.
- Communicates and builds relationships with all levels within the company. Presents solutions and solicits feedback from Senior Management and stakeholder groups. Deputizes for Scientific Leader or Associate Director as necessary.
- Responsible for writing, reviewing and approving protocols and reports in support of projects.
- Works in compliance with all established Safe Work Practices (SWP) and the company SOPs and SODs that enforce them. Understands the requirements and responsibilities for Safety, Health and Environment for Supervisors, and ensures that these are applied
- Works collaboratively with others in the same department and with all stakeholders to achieve agreed objectives. Assists with resolving issues escalated from more junior staff. Escalates issues further as necessary.
- Organizes, chairs and reports on meetings held to resolve technical and operational issues.
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
- Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- All other duties as assigned.
- College / University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
Knowledge, Skills and Abilities
- Expert knowledge of the operational principles of pharmaceutical manufacturing equipment and processes.
- Expert computer skills for Microsoft Office (Word, Excel, Powerpoint, Outlook and JMP).
- Capable of interrogating and finding data in Apotex standard computer systems (SAP, LIMS, Validator, AQRS/QMS). Qualified to make standard entries in SAP and QMS systems.
- Excellent verbal English communication skill sufficient to present ideas and proposals in to all levels in the organization.
- Excellent document and report writing and reviewing skills, capable of conveying information and proposals logically, clearly and unambiguously.
- Capable of completing project assignments independently and with good time management, escalating for clarification or decisions as necessary.
- Minimum of eight years of relevant working or research experience in the pharmaceutical or related industry, ideally with experience in solid dose development or manufacture.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers 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.