Scientific Leader - Liquid Manufacturing

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 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 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.

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