Scientific Leader - Liquid Manufacturing

• 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 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 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.

• 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 liquid dosage forms, scale up and/or technology transfer.

Apotex