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.
PDNA New Product Launch is responsible and accountable for the preparation of new products for launch under Technical Operations scope of activities.
These activities include documentation, monitoring of Process Validation, manufacturing of Launch, Site Transfer and stability batches, and any required process optimization, investigation and / or production troubleshooting as needed.
PDNA- New Product Launch works closely with external groups such as Formulation Development, Regulatory Affairs, Launch, Quality and Operations.
As such, the role requires flexibility to work off-shift, weekends and holidays as needed to support the business.
Investigates formulation and manufacturing process deficiencies for products being manufactured in order to determine the root causes and to recommend solutions for improvement.
Acts as a Subject Matter Expert (SME) during the investigation for all out of specification and / or out of trend results products in production.
Arrange and conduct trials for scale up batches and author technical reports with minimum assistance from the Scientific Leader.
Monitors and supervises full-scale manufacture of products, as required, to provide technical support and / or technology transfer to the manufacturing departments.
Author investigational reports, project summaries, project updates, and provide recommendations to the Scientific Leader, as required.
Able to interpret (e.g. Dissolution, assay, and content uniformity) data obtained from trials, and make recommendations for stability batches, reprocessing and batch failures as required.
Evaluate data using statistical tools for validity of results for implementation in consultation with the Scientific Leader.
Responsible for the preparation of documentation and obtains the necessary approvals to support Change Control Forms to change the Master Formulae of Production, SAP Recipes and Certificates of Analysis.
Responsible and Accountable for investigation and root cause determination of Quality Notifications and review of draft Master Formulae issued for Technical Operations.
Provides support to the Pharmacovigilence Department and Customer Service Department concerning customer complaints.
Applies strong analytical / problem solving skills and utilizes all available resources to correctly identify process and / or formulation deficiencies and is proactive in implementing a solution.
Attends and accountable for appropriate training, seminars and presentations to maintain expertise in formulation development, manufacturing equipment and processes, raw materials, pharmaceutical technologies, and related areas.
Provides professional expertise and perform consultations on issues regarding process optimization, process improvement, optimum utilization of equipment to other members of the Technical Operations department and other Manufacturing departments.
Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
Works as a member of a team to achieve all outcomes;
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
Performs all work in support of our Values : Collaboration, Courage, Perseverance, and Passion and
All other relevant duties as assigned.
College / University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science.
Minimum of five to seven years successful relevant working experience in the pharmaceutical industry.
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).
Excellent Multi-tasking and project / time management skills.
Ability to work independently and make responsible and accountable decisions.
Capable of issuing an investigation in QMS and CCRs 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 guidelines.
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.